{"id":14084,"date":"2021-12-09T16:28:20","date_gmt":"2021-12-09T15:28:20","guid":{"rendered":"https:\/\/phatocon.com\/home\/"},"modified":"2024-12-02T17:40:59","modified_gmt":"2024-12-02T16:40:59","slug":"home","status":"publish","type":"page","link":"https:\/\/phatocon.com\/en\/","title":{"rendered":"Home"},"content":{"rendered":"<section class=\"l-section wpb_row height_auto color_alternate\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-6 vc_hidden-sm vc_hidden-xs wpb_column vc_column_container stretched\"><div class=\"vc_column-inner us_custom_aef3ccd3\"><div class=\"wpb_wrapper\"><section class=\"l-section wpb_row hide_on_tablets hide_on_mobiles height_auto width_full with_video\"><div id=\"us_bg_video_c833\" class=\"l-section-video\"><script>!function(w){var node = document.getElementById( 'us_bg_video_c833' );if ( w.innerWidth <= 10 ) { node.remove() }}(window);<\/script><style>@media(max-width:10px){#us_bg_video_c833{display:none!important}}<\/style><video  autoplay loop muted playsinline preload=\"auto\"><source type=\"video\/mp4\" src=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1823011815.mp4\" \/><\/video><\/div><div class=\"l-section-overlay\" style=\"background:linear-gradient(-90deg, rgba(8,43,79,1) 3%, rgba(8,43,79,0.89) 20%, rgba(8,43,79,0.59) 42%, rgba(8,43,79,0.07) 62%, rgba(8,43,79,0) 88%)\"><\/div><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator hide_on_laptops hide_on_tablets hide_on_mobiles size_custom\" style=\"height:calc(88vh - 95px)\"><\/div><div class=\"w-separator hide_on_default hide_on_tablets hide_on_mobiles size_custom\" style=\"height:55vh\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-6 vc_col-md-6 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_a7a57602 us_animate_this\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row hide_on_default hide_on_laptops via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_b62ec914\"><div class=\"wpb_wrapper\"><section class=\"l-section wpb_row height_auto with_video\"><div id=\"us_bg_video_n72c\" class=\"l-section-video\"><script>!function(w){var node = document.getElementById( 'us_bg_video_n72c' );if ( w.innerWidth <= 10 ) { node.remove() }}(window);<\/script><style>@media(max-width:10px){#us_bg_video_n72c{display:none!important}}<\/style><video  autoplay loop muted playsinline preload=\"auto\"><source type=\"video\/mp4\" src=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1823011815.mp4\" \/><\/video><\/div><div class=\"l-section-overlay\" style=\"background:linear-gradient(360deg, rgba(8,43,79,1) 3%, rgba(8,43,79,0.89) 20%, rgba(8,43,79,0.59) 42%, rgba(8,43,79,0.07) 62%, rgba(8,43,79,0) 88%)\"><\/div><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator hide_on_mobiles size_custom\" style=\"height:390px\"><\/div><div class=\"w-separator hide_on_default hide_on_laptops hide_on_tablets size_custom\" style=\"height:270px\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><\/div><\/div><\/div><div class=\"w-separator hide_on_tablets hide_on_mobiles size_small\"><\/div><div class=\"wpb_text_column gradient-text-dark\"><div class=\"wpb_wrapper\"><h6>Pharm \/Tox Concept<\/h6>\n<\/div><\/div><div class=\"w-separator hide_on_mobiles size_small\"><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h1>Preclinical toxicology and medical safety for <span class=\"gradient-text-dark\">pharmaceuticals and medical devices<\/span><\/h1>\n<\/div><\/div><div class=\"w-separator size_custom with_line width_default thick_1 style_solid color_border align_center\" style=\"height:45px\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"w-iconbox us_custom_12d5294c iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-primary);--icon-bg-color:var(--color-alt-content-bg-alt);\"><i class=\"fal fa-long-arrow-right\"><\/i><\/div><div class=\"w-iconbox-meta\"><p class=\"w-iconbox-title\">Do you have unexpected data or difficulties interpreting the results?<\/p><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:11px\"><\/div><div class=\"w-iconbox us_custom_12d5294c iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-primary);--icon-bg-color:var(--color-alt-content-bg-alt);\"><i class=\"fal fa-long-arrow-right\"><\/i><\/div><div class=\"w-iconbox-meta\"><p class=\"w-iconbox-title\">&#8230; or would you like a second opinion?<\/p><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:11px\"><\/div><div class=\"w-iconbox us_custom_12d5294c iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-primary);--icon-bg-color:var(--color-alt-content-bg-alt);\"><i class=\"fal fa-long-arrow-right\"><\/i><\/div><div class=\"w-iconbox-meta\"><p class=\"w-iconbox-title\">&#8230; or need a sparring partner?<\/p><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:11px\"><\/div><div class=\"w-iconbox us_custom_521a88bd has_text_color iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:#ffffff;--icon-bg-color:var(--color-content-primary);\"><i class=\"fal fa-long-arrow-right\"><\/i><\/div><div class=\"w-iconbox-meta\"><p class=\"w-iconbox-title\">\u2018Take the fast lane\u2019 for your support!<\/p><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:11px\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-btn-wrapper align_none\"><a class=\"w-btn us-btn-style_1\" href=\"https:\/\/phatocon.com\/en\/free-consultation\/\"><span class=\"w-btn-label\">Free consultation<\/span><\/a><\/div><div class=\"w-btn-wrapper align_none\"><a class=\"w-btn us-btn-style_36\" href=\"#losungen\"><span class=\"w-btn-label\">Our solutions<\/span><\/a><\/div><div class=\"w-separator hide_on_tablets hide_on_mobiles size_small\"><\/div><div class=\"w-separator hide_on_default hide_on_laptops size_huge\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator size_large\"><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-4 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-image rundkomplett align_none\"><div class=\"w-image-h\"><img decoding=\"async\" width=\"1024\" height=\"874\" src=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/phatocom-worum-1024x874.jpg\" class=\"attachment-large size-large\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/phatocom-worum-1024x874.jpg 1024w, https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/phatocom-worum-300x256.jpg 300w, https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/phatocom-worum.jpg 1306w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/div><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-8 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_e75d7275\"><div class=\"wpb_wrapper\"><div class=\"w-separator hide_on_default hide_on_laptops hide_on_tablets size_medium\"><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h2 style=\"text-align: left;\">What is this <span class=\"gradient-text-dark\">actually about?<\/span><\/h2>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h5 style=\"text-align: left;\">This is about biocompatibility, i.e. the biological compatibility of medical devices and pharmaceutical products.<\/h5>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p style=\"text-align: left;\">This means that a product used in medicine must not have any avoidable adverse effects on the patient or user&#8230; and this must be proven before it is used on humans. ISO 10993 is the guideline that describes the biological and medical criteria to be applied when testing the biocompatibility of medical devices. This includes a series of biological endpoints such as toxicity and immune compatibility as well as physical\/chemical methods for the chemical characterisation of the products or the materials used and the raw, auxiliary and operating materials. Here, particular attention is paid to impurities, e.g. from the production process, as well as to substances that can be extracted and washed out of the materials.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row us_custom_3db3bbbc height_huge\" id=\"wer\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-12 vc_col-lg-6 vc_col-md-6 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_ca08f164\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h2>Who <span class=\"gradient-text-dark\">we are<\/span><\/h2>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Pharm\/Tox Concept was founded over 10 years ago to offer regulatory testing services for life science companies such as pharmaceutical and medical device manufacturers. Today we represent a competence network of doctors, scientists and technicians and are active in the exciting area of research and development of new products and work with small &#8220;start-ups&#8221; through to &#8220;global players&#8221;.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-6 vc_col-md-6 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_3a2bcdd9\"><div class=\"wpb_wrapper\"><div class=\"w-separator size_small\"><\/div><div class=\"w-separator hide_on_default hide_on_laptops size_medium\"><\/div><div class=\"w-image rundkomplett has_ratio align_none\"><div class=\"w-image-h\"><div style=\"padding-bottom:75%\"><\/div><img decoding=\"async\" width=\"800\" height=\"531\" src=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/20220211__KAP0121-Bearbeitet_800px.jpg\" class=\"attachment-full size-full\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/20220211__KAP0121-Bearbeitet_800px.jpg 800w, https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/20220211__KAP0121-Bearbeitet_800px-300x199.jpg 300w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"wpb_text_column us_custom_c6720a58 has_text_color\"><div class=\"wpb_wrapper\"><p style=\"text-align: center;\"><em>Dr. Thomas Becker<\/em><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row height_auto color_alternate\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-12 vc_col-lg-6 vc_col-md-6 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_2853d680 us_animate_this\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row hide_on_default hide_on_laptops via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container has_bg_color\"><div class=\"vc_column-inner us_custom_7e1a9b6f\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(360deg, rgba(8,43,79,1) 3%, rgba(8,43,79,0.89) 20%, rgba(8,43,79,0.59) 42%, rgba(8,43,79,0.07) 62%, rgba(8,43,79,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><div class=\"w-separator hide_on_tablets hide_on_mobiles size_small\"><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h2>How we can <span class=\"gradient-text-dark\">support<\/span> you<\/h2>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>\u2018Pharm\/Tox Concept\u2019 offers high-quality and competent solutions for chemical and biological testing and product evaluation worldwide to support you in complying with the ISO 10993 series of standards in particular. This is done independently, scientifically, transparently and reliably in close coordination with the requirements of the authorities and our customers and in compliance with the applicable quality management systems.<br \/>\nIn addition to the application of international standards, in particular the ISO 10993 series, our core competence lies in the creation of safety concepts (Biological Evaluation Plan (BER)), the evaluation of studies (Toxicological Risk Assessment (TRA)) and the final determination of biocompatibility (Biological Evaluation Report (BER)). We accompany your project from start to finish and ensure that resources are utilised efficiently and deadlines are met.<\/p>\n<\/div><\/div><div class=\"w-separator hide_on_tablets hide_on_mobiles size_small\"><\/div><div class=\"w-separator hide_on_default hide_on_laptops size_medium\"><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-6 vc_hidden-sm vc_hidden-xs wpb_column vc_column_container stretched\"><div class=\"vc_column-inner us_custom_920ca0ed\"><div class=\"wpb_wrapper\"><section class=\"l-section wpb_row hide_on_tablets hide_on_mobiles height_auto width_full with_video\"><div id=\"us_bg_video_g20a\" class=\"l-section-video\"><script>!function(w){var node = document.getElementById( 'us_bg_video_g20a' );if ( w.innerWidth <= 10 ) { node.remove() }}(window);<\/script><style>@media(max-width:10px){#us_bg_video_g20a{display:none!important}}<\/style><video  autoplay loop muted playsinline preload=\"auto\"><source type=\"video\/mp4\" src=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-924766568.mp4\" \/><\/video><\/div><div class=\"l-section-overlay\" style=\"background:linear-gradient(90deg, rgba(8,43,79,1) 3%, rgba(8,43,79,0.89) 20%, rgba(8,43,79,0.59) 42%, rgba(8,43,79,0.07) 62%, rgba(8,43,79,0) 88%)\"><\/div><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator hide_on_laptops hide_on_tablets hide_on_mobiles size_custom\" style=\"height:calc(88vh - 95px)\"><\/div><div class=\"w-separator hide_on_default hide_on_tablets hide_on_mobiles size_custom\" style=\"height:55vh\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row us_custom_c70c97eb height_auto\" id=\"losungen\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-2 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"vc_col-sm-8 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator size_large\"><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h2 style=\"text-align: center;\"><span class=\"gradient-text-dark\">Solutions<\/span> are our goal<\/h2>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p style=\"text-align: center;\">Throughout the entire project, PhaToCon is your contact for all toxicological questions. Maximum legal certainty is an important component of our solutions; scientific competence and experience are at least equivalent. We work holistically, taking into account all available information, regulatory, scientific and technical.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_medium\"><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-2 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row us_custom_c70c97eb height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-6 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-grid type_grid layout_13413\" id=\"us_grid_1\" style=\"--gap:1.5rem;\"><style>.layout_13413 .w-grid-item-h{border-radius:1.5rem}.layout_13413 .usg_vwrapper_1{transition-duration:1.1s;transform-origin:50% 50%;transform:scale(1) translate(0%,0%)}.layout_13413 .w-grid-item-h:hover .usg_vwrapper_1{transform:scale(1.03) translate(0%,0%);opacity:1;border-color:var(--color-content-primary)!important}.layout_13413 .usg_vwrapper_1{border-radius:1.6rem!important;border-color:var(--color-content-bg-alt)!important;border-width:3px!important;background:var(--color-content-bg)!important}<\/style><div class=\"w-grid-list\">\t<article class=\"w-grid-item size_1x1 post-14129 post type-post status-publish format-standard hentry category-unkategorisiert\" data-id=\"14129\">\r\n\t\t<div class=\"w-grid-item-h\">\r\n\t\t\t\t\t\t<div class=\"w-vwrapper usg_vwrapper_1 align_none valign_top\"><div class=\"w-post-elm post_content usg_post_content_1\"><section class=\"l-section wpb_row height_auto width_full\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-6 vc_hidden-md vc_hidden-sm vc_hidden-xs wpb_column vc_column_container has_bg_color\" id=\"gradientrechts\"><div class=\"vc_column-inner us_custom_37b2812c\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(-90deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-6 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_870fb40f\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row hide_on_default via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container gradientunten has_bg_color\"><div class=\"vc_column-inner us_custom_e086fdbb\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(360deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><div class=\"wpb_text_column us_custom_3090c82c\"><div class=\"wpb_wrapper\"><h4><span style=\"color: #18add9;\">1.<\/span> CHEMICAL CHARACTERIZATION<\/h4>\n<\/div><\/div><div class=\"wpb_text_column us_custom_26060442\"><div class=\"wpb_wrapper\"><p>Identification and quantification of extractables and leachables (E&amp;L)<\/p>\n<\/div><\/div><div class=\"w-popup w-btn-wrapper align_none\"><button aria-label=\"Read more\" class=\"w-popup-trigger type_btn w-btn us-btn-style_59 icon_atright\"><span class=\"w-btn-label\">Read more<\/span><i class=\"fal fa-long-arrow-right\"><\/i><\/button><div class=\"w-popup-overlay\" style=\"background:rgba(0,0,0,0.25);\"><\/div><div class=\"w-popup-wrap layout_right_panel\" style=\"--title-color:var(--color-content-heading);--title-bg-color:var(--color-content-bg-alt);--content-color:;--content-bg-color:var(--color-content-bg);--popup-width:800px;--popup-padding:0px;\"><div class=\"w-popup-box animation_slideRight closerpos_inside without_title\"><div class=\"w-popup-box-h\"><div class=\"w-popup-box-content\"><section class=\"l-section wpb_row height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator size_medium\"><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_07960d64\"><div class=\"wpb_wrapper\"><h3>Chemical characterization<\/h3>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Identification and quantification of extractables and leachables (E&amp;L)<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_9c33410b gradient-text-dark\"><div class=\"wpb_wrapper\"><h5>CHEMICAL CHARACTERIZATION FOR MORE SAFETY OF MEDICAL DEVICES<\/h5>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>According to the biocompatibility standard ISO 10993-1, information on the chemical composition must be obtained for all medical devices. As a result, chemical characterization is required for most medical devices, from low-risk products such as plasters or medical spatulas to high-risk products such as implants. Analyzing the chemical substances released from a device into the patient&#8217;s body enables the prediction and reduction of potential toxicities.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_9c33410b gradient-text-dark\"><div class=\"wpb_wrapper\"><h5>WHICH PHYSICAL\/CHEMICAL METHODS ARE SUITABLE FOR CHEMICAL CHARACTERIZATION?<\/h5>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>In the chemical characterization of medical devices according to ISO 10993-18, volatile, semi-volatile and non-volatile organic and inorganic substances are analyzed using various methods and techniques. Using suitable methods these substances are extracted or washed out of the products and provide an overview of potentially undesirable substances released during use. This chemical profile is used to assess the overall risk to the patient or user when using the product.<br \/>\nThe analytical methods used for this purpose are high-resolution and sensitive techniques. Depending on the hazard potential of the products, the following methods are usually used:<\/p>\n<\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><\/div><\/div><\/div><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Inductively coupled plasma mass spectrometry (ICP-MS)<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Analytical method used to screen for metallic and inorganic elements in the chemical characterization of medical devices.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Gas chromatography with vapor phase (head space) separation and coupled mass spectrometry (HS GC-MS)<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Analytical method for the identification and quantification of volatile organic molecules (VOC).<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Gas chromatography with coupled mass spectrometry (GC-MS)<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Analytical method for the separation and identification of semi-volatile organic molecules (SVOC) up to a molecular weight of approx. 600 Da.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Liquid chromatography with coupled mass spectrometry (LC-MS)<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Analytical method for the separation and identification of non-volatile organic molecules (NVOC) as part of the chemical characterization of medical devices.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_medium\"><\/div><div class=\"w-separator size_medium\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><div class=\"w-popup-closer\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><\/div>\t\t<\/div>\r\n\t\t\t<\/article>\r\n<\/div><style id=\"grid-post-content-css\">.us_custom_37b2812c{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1418835107.jpg) 50% 50% \/ cover!important}.us_custom_870fb40f{text-align:inherit!important;margin-left:-3vw!important;margin-right:1.5rem!important;border-radius:1.5rem!important;position:relative!important;z-index:8!important;padding:3rem!important}.us_custom_e086fdbb{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1418835107.jpg) 50% 50% \/ cover!important}.us_custom_3090c82c{margin-bottom:10px!important}.us_custom_26060442{font-size:17px!important;line-height:1.6!important}@media (min-width:1001px) and (max-width:1150px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}@media (min-width:601px) and (max-width:1000px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}@media (max-width:600px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}<\/style><div class=\"w-grid-preloader\">\t<div class=\"g-preloader type_1\">\r\n\t\t<div><\/div>\r\n\t<\/div>\r\n\t<\/div>\t<div class=\"w-grid-json hidden\" onclick='return {&quot;action&quot;:&quot;us_ajax_grid&quot;,&quot;infinite_scroll&quot;:0,&quot;max_num_pages&quot;:1,&quot;pagination&quot;:&quot;none&quot;,&quot;template_vars&quot;:{&quot;columns&quot;:&quot;1&quot;,&quot;exclude_items&quot;:&quot;none&quot;,&quot;img_size&quot;:&quot;default&quot;,&quot;ignore_items_size&quot;:0,&quot;items_layout&quot;:&quot;13413&quot;,&quot;items_offset&quot;:&quot;1&quot;,&quot;load_animation&quot;:&quot;none&quot;,&quot;overriding_link&quot;:&quot;%7B%22url%22%3A%22%22%7D&quot;,&quot;post_id&quot;:0,&quot;query_args&quot;:{&quot;ignore_sticky_posts&quot;:1,&quot;post_type&quot;:&quot;any&quot;,&quot;post__in&quot;:[&quot;13519&quot;],&quot;posts_per_page&quot;:&quot;10&quot;},&quot;orderby_query_args&quot;:{&quot;orderby&quot;:{&quot;date&quot;:&quot;DESC&quot;}},&quot;type&quot;:&quot;grid&quot;,&quot;us_grid_post_type&quot;:&quot;ids&quot;,&quot;us_grid_ajax_index&quot;:1,&quot;us_grid_filter_params&quot;:[],&quot;us_grid_index&quot;:1,&quot;page_args&quot;:[],&quot;lang&quot;:&quot;en&quot;}}'><\/div>\r\n\t<\/div><div class=\"w-separator size_custom\" style=\"height:3rem\"><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-6 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-grid type_grid layout_13413\" id=\"us_grid_2\" style=\"--gap:1.5rem;\"><div class=\"w-grid-list\">\t<article class=\"w-grid-item size_1x1 post-14178 post type-post status-publish format-standard hentry category-unkategorisiert\" data-id=\"14178\">\r\n\t\t<div class=\"w-grid-item-h\">\r\n\t\t\t\t\t\t<div class=\"w-vwrapper usg_vwrapper_1 align_none valign_top\"><div class=\"w-post-elm post_content usg_post_content_1\"><section class=\"l-section wpb_row height_auto width_full\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-6 vc_hidden-md vc_hidden-sm vc_hidden-xs wpb_column vc_column_container has_bg_color\" id=\"gradientrechts\"><div class=\"vc_column-inner us_custom_005f1b5e\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(-90deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-6 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_870fb40f\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row hide_on_default via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container gradientunten has_bg_color\"><div class=\"vc_column-inner us_custom_29547bd8\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(360deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><div class=\"wpb_text_column us_custom_3090c82c\"><div class=\"wpb_wrapper\"><h4><span style=\"color: #18add9;\">2.<\/span> TOXICOLOGICAL RISK ASSESSMENT<\/h4>\n<\/div><\/div><div class=\"wpb_text_column us_custom_26060442\"><div class=\"wpb_wrapper\"><p>Calculation of safety margins based on toxicity and concentration of identified extractables<\/p>\n<\/div><\/div><div class=\"w-popup w-btn-wrapper align_none\"><button aria-label=\"Read more\" class=\"w-popup-trigger type_btn w-btn us-btn-style_59 icon_atright\"><span class=\"w-btn-label\">Read more<\/span><i class=\"fal fa-long-arrow-right\"><\/i><\/button><div class=\"w-popup-overlay\" style=\"background:rgba(0,0,0,0.25);\"><\/div><div class=\"w-popup-wrap layout_right_panel\" style=\"--title-color:var(--color-content-heading);--title-bg-color:var(--color-content-bg-alt);--content-color:;--content-bg-color:var(--color-content-bg);--popup-width:800px;--popup-padding:0px;\"><div class=\"w-popup-box animation_slideRight closerpos_inside without_title\"><div class=\"w-popup-box-h\"><div class=\"w-popup-box-content\"><section class=\"l-section wpb_row height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator size_medium\"><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_07960d64\"><div class=\"wpb_wrapper\"><h3>TOXICOLOGICAL RISK ASSESSMENT (TRA)<\/h3>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Calculation of safety margins based on toxicity and concentration of identified extractables<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_9c33410b gradient-text-dark\"><div class=\"wpb_wrapper\"><h5>WHAT IS THE TOXICOLOGICAL RISK ASSESSMENT FOR MEDICAL DEVICES?<\/h5>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>A toxicological risk assessment is a comprehensive safety assessment of a device, based on its composition, the materials used and taking into account the intended use. The detailed scientific report on the toxicological assessment contains all available and relevant information and data on a specific ingredient in relation to the medical device under investigation. This includes the dosage, the concentration and the specific exposure scenario.<\/p>\n<p>The toxicological risk assessment is a scientific evaluation and includes the following activities:<\/p>\n<\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Characterization of substances that can be extracted and leached<\/h5><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Evaluation of exposure<\/h5><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Dose-response assessment<\/h5><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Identification of hazards and evaluation of data<\/h5><\/div><\/div><div class=\"w-separator size_custom\" style=\"height:10px\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left no_text\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Risk characterization<\/h5><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_9c33410b gradient-text-dark\"><div class=\"wpb_wrapper\"><h5>WHY IS TOXICOLOGICAL RISK ASSESSMENT SO IMPORTANT FOR THE SAFETY OF MEDICAL DEVICES?<\/h5>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Properly evaluating and assessing the biological and toxicological risks, posed by extractables or chemical residues that may impact patient safety, is one of the more challenging aspects of the chemical characterization process.<br \/>\nTo control the risk associated with extractable substances, these substances are identified, the related risks are quantified and exposure to these substances is limited so that acceptable limits are not exceeded.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_9c33410b gradient-text-dark\"><div class=\"wpb_wrapper\"><h5>RISK MANAGEMENT?<\/h5>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Risk assessment is an important and essential part of the chemical characterization and biocompatibility testing, since it defines the acceptable limits for extractable and leachable substances.<\/p>\n<p>The ISO 10993 standard series serves as a framework for assessing the biocompatibility of medical devices and the management of biological risks. The specific standards ISO 10993-17 and ISO\/TS 21726 regulate the evaluation criteria for the toxicological risk analysis of the components of medical devices and the determination of the acceptable limit values for extractable substances.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_medium\"><\/div><div class=\"w-separator size_medium\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><div class=\"w-popup-closer\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row height_auto width_full\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><\/div>\t\t<\/div>\r\n\t\t\t<\/article>\r\n<\/div><style id=\"grid-post-content-css\">.us_custom_37b2812c{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1418835107.jpg) 50% 50% \/ cover!important}.us_custom_870fb40f{text-align:inherit!important;margin-left:-3vw!important;margin-right:1.5rem!important;border-radius:1.5rem!important;position:relative!important;z-index:8!important;padding:3rem!important}.us_custom_e086fdbb{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1418835107.jpg) 50% 50% \/ cover!important}.us_custom_3090c82c{margin-bottom:10px!important}.us_custom_26060442{font-size:17px!important;line-height:1.6!important}.us_custom_005f1b5e{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1421547005.jpg) 50% 50% \/ cover!important}.us_custom_29547bd8{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1421547005.jpg) 50% 50% \/ cover!important}@media (min-width:1001px) and (max-width:1150px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}@media (min-width:601px) and (max-width:1000px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}@media (max-width:600px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}<\/style><div class=\"w-grid-preloader\">\t<div class=\"g-preloader type_1\">\r\n\t\t<div><\/div>\r\n\t<\/div>\r\n\t<\/div>\t<div class=\"w-grid-json hidden\" onclick='return {&quot;action&quot;:&quot;us_ajax_grid&quot;,&quot;infinite_scroll&quot;:0,&quot;max_num_pages&quot;:1,&quot;pagination&quot;:&quot;none&quot;,&quot;template_vars&quot;:{&quot;columns&quot;:&quot;1&quot;,&quot;exclude_items&quot;:&quot;none&quot;,&quot;img_size&quot;:&quot;default&quot;,&quot;ignore_items_size&quot;:0,&quot;items_layout&quot;:&quot;13413&quot;,&quot;items_offset&quot;:&quot;1&quot;,&quot;load_animation&quot;:&quot;none&quot;,&quot;overriding_link&quot;:&quot;%7B%22url%22%3A%22%22%7D&quot;,&quot;post_id&quot;:0,&quot;query_args&quot;:{&quot;ignore_sticky_posts&quot;:1,&quot;post_type&quot;:&quot;any&quot;,&quot;post__in&quot;:[&quot;13699&quot;],&quot;posts_per_page&quot;:&quot;10&quot;},&quot;orderby_query_args&quot;:{&quot;orderby&quot;:{&quot;date&quot;:&quot;DESC&quot;}},&quot;type&quot;:&quot;grid&quot;,&quot;us_grid_post_type&quot;:&quot;ids&quot;,&quot;us_grid_ajax_index&quot;:2,&quot;us_grid_filter_params&quot;:[],&quot;us_grid_index&quot;:2,&quot;page_args&quot;:[],&quot;lang&quot;:&quot;en&quot;}}'><\/div>\r\n\t<\/div><div class=\"w-separator size_custom\" style=\"height:3rem\"><\/div><\/div><\/div><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-6 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-grid type_grid layout_13413\" id=\"us_grid_3\" style=\"--gap:1.5rem;\"><div class=\"w-grid-list\">\t<article class=\"w-grid-item size_1x1 post-14174 post type-post status-publish format-standard hentry category-unkategorisiert\" data-id=\"14174\">\r\n\t\t<div class=\"w-grid-item-h\">\r\n\t\t\t\t\t\t<div class=\"w-vwrapper usg_vwrapper_1 align_none valign_top\"><div class=\"w-post-elm post_content usg_post_content_1\"><section class=\"l-section wpb_row height_auto width_full\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-6 vc_hidden-md vc_hidden-sm vc_hidden-xs wpb_column vc_column_container has_bg_color\" id=\"gradientrechts\"><div class=\"vc_column-inner us_custom_8e6a97a4\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(-90deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-6 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_870fb40f\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row hide_on_default via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container gradientunten has_bg_color\"><div class=\"vc_column-inner us_custom_63e85b32\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(360deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><div class=\"wpb_text_column us_custom_3090c82c\"><div class=\"wpb_wrapper\"><h4><span style=\"color: #18add9;\">3.<\/span> BIOLOGICAL \/ TOXICOLOGICAL ENDPOINTS<\/h4>\n<\/div><\/div><div class=\"wpb_text_column us_custom_26060442\"><div class=\"wpb_wrapper\"><p>Identification of biological effects after exposure<\/p>\n<\/div><\/div><div class=\"w-popup w-btn-wrapper align_none\"><button aria-label=\"Read more\" class=\"w-popup-trigger type_btn w-btn us-btn-style_59 icon_atright\"><span class=\"w-btn-label\">Read more<\/span><i class=\"fal fa-long-arrow-right\"><\/i><\/button><div class=\"w-popup-overlay\" style=\"background:rgba(0,0,0,0.25);\"><\/div><div class=\"w-popup-wrap layout_right_panel\" style=\"--title-color:var(--color-content-heading);--title-bg-color:var(--color-content-bg-alt);--content-color:;--content-bg-color:var(--color-content-bg);--popup-width:800px;--popup-padding:0px;\"><div class=\"w-popup-box animation_slideRight closerpos_inside without_title\"><div class=\"w-popup-box-h\"><div class=\"w-popup-box-content\"><section class=\"l-section wpb_row height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator size_medium\"><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_07960d64\"><div class=\"wpb_wrapper\"><h3>BIOLOGICAL\/TOXICOLOGICAL ENDPOINTS<\/h3>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p><span style=\"font-weight: 400;\">Identification of biological effects after exposure<br \/>\n<\/span><\/p>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Medical devices often come into direct contact with human body tissue or fluids. It is important to check that the material of the device does not cause harmful reactions such as inflammation, allergies or tissue damage.<\/p>\n<p>For the approval of medical devices and to ensure that the products are safe for human use, biological tests are carried out in addition to the physical\/chemical tests. These tests may be decisive not only to confirm the biocompatibility of the individual extractable substances identified, but also to investigate the effect of the extracts as complex mixtures under clinical conditions and thus minimize potential health risks.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_9c33410b gradient-text-dark\"><div class=\"wpb_wrapper\"><h5>WHAT ARE THE BIOLOGICAL ENDPOINTS FOR ASSESSING BIOCOMPATIBILITY?<\/h5>\n<\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Cytotoxicity &#8211; ISO 10993-5<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Cytotoxicity tests determine the general degree of toxicity of medical devices or their material, i.e. the potential for non-specific cell damage, by means of an elution test or agarose overlay test in cell cultures. A cytotoxicity test is a comparatively inexpensive and very sensitive method of determining the toxic effect of medical devices.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Genotoxicity &#8211; ISO 10993-3 and FDA<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Genotoxicity tests are used to detect toxins that can interact with and possibly modify the genetic material of cells. This is to ensure that the substances do not cause genetic changes that can lead to cancer or other serious diseases.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Hemocompatibility &#8211; ISO 10993-4 and ASTM<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Hemocompatibility tests use hematology and thrombosis tests to evaluate the effects of medical devices in contact with human blood and blood components. Devices that come into contact with blood (e.g. catheters or heart valves) must be tested to ensure that they do not cause blood clots or hemolysis.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Irritation &#8211; ISO 10993-23<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Skin irritation tests assess medical devices for their potential skin damaging\/irritating effects. For this purpose, skin and eye reaction tests, intracutaneous reaction tests and in vitro tests for skin irritation are performed.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Sensitization &#8211; ISO 10993-10<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">Sensitization tests are performed to assess possible immune reactions using in vivo and in vitro test methods. The extent to which the products can trigger allergic reactions is investigated.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Systemic effects of potential toxicity and pyrogenicity &#8211; ISO 10993-11 and ASTM<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">These are tests for acute to chronic systemic toxicity from substances that may be harmful to the body. Pyrogenicity tests prove medical devices for fever-causing substances, so-called pyrogens, which affects patients coming into contact with the medical device.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-iconbox iconpos_left style_circle color_custom align_left\"><div class=\"w-iconbox-icon\" style=\"font-size:14px;--icon-color:var(--color-content-link);--icon-bg-color:var(--color-content-bg-alt);\"><i class=\"fal fa-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\" style=\"font-size:17px;\">Testing for implantation effects &#8211; ISO 10993-6<\/h5><div class=\"w-iconbox-text\"><p style=\"font-size: 16px; line-height: 26px;\">These tests assess histologically and pathologically how medical devices affect the surrounding living tissue. The aim is to ensure that there are no negative effects on the surrounding tissue, such as scarring or rejection reactions.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_small\"><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>There are numerous other testing methods and biological endpoints. All of these tests are part of a comprehensive risk management process and are often carried out in accordance with international standards such as ISO 10993. Ultimately, they serve to protect and ensure the safety of patients and confirm the reliability and effectiveness of medical devices.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_medium\"><\/div><div class=\"w-separator size_medium\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><div class=\"w-popup-closer\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><\/div>\t\t<\/div>\r\n\t\t\t<\/article>\r\n<\/div><style id=\"grid-post-content-css\">.us_custom_37b2812c{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1418835107.jpg) 50% 50% \/ cover!important}.us_custom_870fb40f{text-align:inherit!important;margin-left:-3vw!important;margin-right:1.5rem!important;border-radius:1.5rem!important;position:relative!important;z-index:8!important;padding:3rem!important}.us_custom_e086fdbb{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1418835107.jpg) 50% 50% \/ cover!important}.us_custom_3090c82c{margin-bottom:10px!important}.us_custom_26060442{font-size:17px!important;line-height:1.6!important}.us_custom_005f1b5e{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1421547005.jpg) 50% 50% \/ cover!important}.us_custom_29547bd8{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1421547005.jpg) 50% 50% \/ cover!important}.us_custom_8e6a97a4{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1024119864.jpg) 50% 50% \/ cover!important}.us_custom_63e85b32{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1024119864.jpg) 50% 50% \/ cover!important}@media (min-width:1001px) and (max-width:1150px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}@media (min-width:601px) and (max-width:1000px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}@media (max-width:600px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}<\/style><div class=\"w-grid-preloader\">\t<div class=\"g-preloader type_1\">\r\n\t\t<div><\/div>\r\n\t<\/div>\r\n\t<\/div>\t<div class=\"w-grid-json hidden\" onclick='return {&quot;action&quot;:&quot;us_ajax_grid&quot;,&quot;infinite_scroll&quot;:0,&quot;max_num_pages&quot;:1,&quot;pagination&quot;:&quot;none&quot;,&quot;template_vars&quot;:{&quot;columns&quot;:&quot;1&quot;,&quot;exclude_items&quot;:&quot;none&quot;,&quot;img_size&quot;:&quot;default&quot;,&quot;ignore_items_size&quot;:0,&quot;items_layout&quot;:&quot;13413&quot;,&quot;items_offset&quot;:&quot;1&quot;,&quot;load_animation&quot;:&quot;none&quot;,&quot;overriding_link&quot;:&quot;%7B%22url%22%3A%22%22%7D&quot;,&quot;post_id&quot;:0,&quot;query_args&quot;:{&quot;ignore_sticky_posts&quot;:1,&quot;post_type&quot;:&quot;any&quot;,&quot;post__in&quot;:[&quot;13703&quot;],&quot;posts_per_page&quot;:&quot;10&quot;},&quot;orderby_query_args&quot;:{&quot;orderby&quot;:{&quot;date&quot;:&quot;DESC&quot;}},&quot;type&quot;:&quot;grid&quot;,&quot;us_grid_post_type&quot;:&quot;ids&quot;,&quot;us_grid_ajax_index&quot;:3,&quot;us_grid_filter_params&quot;:[],&quot;us_grid_index&quot;:3,&quot;page_args&quot;:[],&quot;lang&quot;:&quot;en&quot;}}'><\/div>\r\n\t<\/div><div class=\"w-separator size_custom\" style=\"height:3rem\"><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-6 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-grid type_grid layout_13413\" id=\"us_grid_4\" style=\"--gap:1.5rem;\"><div class=\"w-grid-list\">\t<article class=\"w-grid-item size_1x1 post-14170 post type-post status-publish format-standard hentry category-unkategorisiert\" data-id=\"14170\">\r\n\t\t<div class=\"w-grid-item-h\">\r\n\t\t\t\t\t\t<div class=\"w-vwrapper usg_vwrapper_1 align_none valign_top\"><div class=\"w-post-elm post_content usg_post_content_1\"><section class=\"l-section wpb_row height_auto width_full\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-6 vc_hidden-md vc_hidden-sm vc_hidden-xs wpb_column vc_column_container has_bg_color\" id=\"gradientrechts\"><div class=\"vc_column-inner us_custom_bfdda276\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(-90deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-6 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_870fb40f\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row hide_on_default via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container gradientunten has_bg_color\"><div class=\"vc_column-inner us_custom_63f60c5d\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(360deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><div class=\"wpb_text_column us_custom_3090c82c\"><div class=\"wpb_wrapper\"><h4><span style=\"color: #18add9;\">4.<\/span> OUTSOURCING &amp; PROJECT MANAGEMENT<\/h4>\n<\/div><\/div><div class=\"wpb_text_column us_custom_26060442\"><div class=\"wpb_wrapper\"><p>Identification of suitable contract research organisations (CROs) and competent study monitoring<\/p>\n<\/div><\/div><div class=\"w-popup w-btn-wrapper align_none\"><button aria-label=\"Read more\" class=\"w-popup-trigger type_btn w-btn us-btn-style_59 icon_atright\"><span class=\"w-btn-label\">Read more<\/span><i class=\"fal fa-long-arrow-right\"><\/i><\/button><div class=\"w-popup-overlay\" style=\"background:rgba(0,0,0,0.25);\"><\/div><div class=\"w-popup-wrap layout_right_panel\" style=\"--title-color:var(--color-content-heading);--title-bg-color:var(--color-content-bg-alt);--content-color:;--content-bg-color:var(--color-content-bg);--popup-width:800px;--popup-padding:0px;\"><div class=\"w-popup-box animation_slideRight closerpos_inside without_title\"><div class=\"w-popup-box-h\"><div class=\"w-popup-box-content\"><section class=\"l-section wpb_row height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator size_medium\"><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_07960d64\"><div class=\"wpb_wrapper\"><h3>OUTSOURCING AND PROJECT MANAGEMENT<\/h3>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p><span style=\"font-weight: 400;\">Identification of suitable contract research organisations (CROs) and competent study monitoring<br \/>\n<\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>In addition to qualified scientific and regulatory advice on the selection of studies and test strategies suitable for your objectives, we also offer the implementation of the studies at one of our laboratory partners. From the time the order is placed, we take over the entire handling and support of the studies for you until the successful completion of the project.<\/p>\n<p>On the client&#8217;s side, the study monitor is the essential scientific complement to the study director of the research laboratory (CRO). Only the successful interaction of both positions can ensure that balanced and controlled decisions are made so that data and results meet the requirements of both, the science and the sponsor. Needs-based, results-oriented and scientific study monitoring guarantees the interdisciplinary coordination and assessment of approval-relevant studies for which quality assurance systems such as GLP, GMP and \/ or ISO are mandatory.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_medium\"><\/div><div class=\"w-separator size_medium\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><div class=\"w-popup-closer\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row height_auto width_full\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><\/div>\t\t<\/div>\r\n\t\t\t<\/article>\r\n<\/div><style id=\"grid-post-content-css\">.us_custom_37b2812c{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1418835107.jpg) 50% 50% \/ cover!important}.us_custom_870fb40f{text-align:inherit!important;margin-left:-3vw!important;margin-right:1.5rem!important;border-radius:1.5rem!important;position:relative!important;z-index:8!important;padding:3rem!important}.us_custom_e086fdbb{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1418835107.jpg) 50% 50% \/ cover!important}.us_custom_3090c82c{margin-bottom:10px!important}.us_custom_26060442{font-size:17px!important;line-height:1.6!important}.us_custom_005f1b5e{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1421547005.jpg) 50% 50% \/ cover!important}.us_custom_29547bd8{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1421547005.jpg) 50% 50% \/ cover!important}.us_custom_8e6a97a4{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1024119864.jpg) 50% 50% \/ cover!important}.us_custom_63e85b32{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1024119864.jpg) 50% 50% \/ cover!important}.us_custom_bfdda276{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1600739244.jpg) 50% 50% \/ cover!important}.us_custom_63f60c5d{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/04\/AdobeStock_403234519_Preview.jpeg) 50% 50% \/ cover!important}@media (min-width:1001px) and (max-width:1150px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}@media (min-width:601px) and (max-width:1000px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}@media (max-width:600px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}<\/style><div class=\"w-grid-preloader\">\t<div class=\"g-preloader type_1\">\r\n\t\t<div><\/div>\r\n\t<\/div>\r\n\t<\/div>\t<div class=\"w-grid-json hidden\" onclick='return {&quot;action&quot;:&quot;us_ajax_grid&quot;,&quot;infinite_scroll&quot;:0,&quot;max_num_pages&quot;:1,&quot;pagination&quot;:&quot;none&quot;,&quot;template_vars&quot;:{&quot;columns&quot;:&quot;1&quot;,&quot;exclude_items&quot;:&quot;none&quot;,&quot;img_size&quot;:&quot;default&quot;,&quot;ignore_items_size&quot;:0,&quot;items_layout&quot;:&quot;13413&quot;,&quot;items_offset&quot;:&quot;1&quot;,&quot;load_animation&quot;:&quot;none&quot;,&quot;overriding_link&quot;:&quot;%7B%22url%22%3A%22%22%7D&quot;,&quot;post_id&quot;:0,&quot;query_args&quot;:{&quot;ignore_sticky_posts&quot;:1,&quot;post_type&quot;:&quot;any&quot;,&quot;post__in&quot;:[&quot;13705&quot;],&quot;posts_per_page&quot;:&quot;10&quot;},&quot;orderby_query_args&quot;:{&quot;orderby&quot;:{&quot;date&quot;:&quot;DESC&quot;}},&quot;type&quot;:&quot;grid&quot;,&quot;us_grid_post_type&quot;:&quot;ids&quot;,&quot;us_grid_ajax_index&quot;:4,&quot;us_grid_filter_params&quot;:[],&quot;us_grid_index&quot;:4,&quot;page_args&quot;:[],&quot;lang&quot;:&quot;en&quot;}}'><\/div>\r\n\t<\/div><div class=\"w-separator size_custom\" style=\"height:3rem\"><\/div><\/div><\/div><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-6 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-grid type_grid layout_13413\" id=\"us_grid_5\" style=\"--gap:1.5rem;\"><div class=\"w-grid-list\">\t<article class=\"w-grid-item size_1x1 post-14167 post type-post status-publish format-standard hentry category-unkategorisiert\" data-id=\"14167\">\r\n\t\t<div class=\"w-grid-item-h\">\r\n\t\t\t\t\t\t<div class=\"w-vwrapper usg_vwrapper_1 align_none valign_top\"><div class=\"w-post-elm post_content usg_post_content_1\"><section class=\"l-section wpb_row height_auto width_full\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-6 vc_hidden-md vc_hidden-sm vc_hidden-xs wpb_column vc_column_container has_bg_color\" id=\"gradientrechts\"><div class=\"vc_column-inner us_custom_0c08878b\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(-90deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-6 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_870fb40f\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row hide_on_default via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container gradientunten has_bg_color\"><div class=\"vc_column-inner us_custom_1728e0bc\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(360deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><div class=\"wpb_text_column us_custom_3090c82c\"><div class=\"wpb_wrapper\"><h4><span style=\"color: #18add9;\">5.<\/span> QUALITY MANAGEMENT IN RESEARCH &amp; DEVELOPMENT<\/h4>\n<\/div><\/div><div class=\"wpb_text_column us_custom_26060442\"><div class=\"wpb_wrapper\"><p>Tools for continuous improvement<\/p>\n<\/div><\/div><div class=\"w-popup w-btn-wrapper align_none\"><button aria-label=\"Read more\" class=\"w-popup-trigger type_btn w-btn us-btn-style_59 icon_atright\"><span class=\"w-btn-label\">Read more<\/span><i class=\"fal fa-long-arrow-right\"><\/i><\/button><div class=\"w-popup-overlay\" style=\"background:rgba(0,0,0,0.25);\"><\/div><div class=\"w-popup-wrap layout_right_panel\" style=\"--title-color:var(--color-content-heading);--title-bg-color:var(--color-content-bg-alt);--content-color:;--content-bg-color:var(--color-content-bg);--popup-width:800px;--popup-padding:0px;\"><div class=\"w-popup-box animation_slideRight closerpos_inside without_title\"><div class=\"w-popup-box-h\"><div class=\"w-popup-box-content\"><section class=\"l-section wpb_row height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator size_medium\"><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_07960d64\"><div class=\"wpb_wrapper\"><h3>QUALITY MANAGEMENT IN RESEARCH AND DEVELOPMENT<\/h3>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p><span style=\"font-weight: 400;\">Tools for continuous improvement<br \/>\n<\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Product safety and risk assessment in the pharmaceutical, biopharmaceutical and medical device sectors are aspects that are already of lasting importance in R&amp;D. You will gain efficiency and precision if you consider today what will be required of you by regulations in the future.<\/p>\n<p>Standardized industrial and regulatory quality management systems (GxP, ISO, &#8230;) and guidelines (OECD, ICH, &#8230;) are used worldwide to ensure the validity and traceability of data, processes and decisions in the life science sector.<\/p>\n<p>In the early R&amp;D phase, these standardized quality assurance systems are not necessarily suitable for promoting creative solutions to problems in research and development &#8211; or for developing innovative products. The challenge for quality management in this phase is therefore to create space for creativity and problem solving and yet generate reliable data.<\/p>\n<p>PhaToCon provides tried-and-tested consultancy and management services in all aspects of preclinical toxicology and accompanying quality management. Processes for change control, deviation management, CAPA (corrective and preventive action) or risk management are the tools for your continuous improvement.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_medium\"><\/div><div class=\"w-separator size_medium\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><div class=\"w-popup-closer\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><\/div>\t\t<\/div>\r\n\t\t\t<\/article>\r\n<\/div><style id=\"grid-post-content-css\">.us_custom_37b2812c{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1418835107.jpg) 50% 50% \/ cover!important}.us_custom_870fb40f{text-align:inherit!important;margin-left:-3vw!important;margin-right:1.5rem!important;border-radius:1.5rem!important;position:relative!important;z-index:8!important;padding:3rem!important}.us_custom_e086fdbb{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1418835107.jpg) 50% 50% \/ cover!important}.us_custom_3090c82c{margin-bottom:10px!important}.us_custom_26060442{font-size:17px!important;line-height:1.6!important}.us_custom_005f1b5e{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1421547005.jpg) 50% 50% \/ cover!important}.us_custom_29547bd8{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1421547005.jpg) 50% 50% \/ cover!important}.us_custom_8e6a97a4{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1024119864.jpg) 50% 50% \/ cover!important}.us_custom_63e85b32{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1024119864.jpg) 50% 50% \/ cover!important}.us_custom_bfdda276{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1600739244.jpg) 50% 50% \/ cover!important}.us_custom_63f60c5d{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/04\/AdobeStock_403234519_Preview.jpeg) 50% 50% \/ cover!important}.us_custom_0c08878b{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1470913692.jpg) 50% 50% \/ cover!important}.us_custom_1728e0bc{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1470913692.jpg) 50% 50% \/ cover!important}@media (min-width:1001px) and (max-width:1150px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}@media (min-width:601px) and (max-width:1000px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}@media (max-width:600px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}<\/style><div class=\"w-grid-preloader\">\t<div class=\"g-preloader type_1\">\r\n\t\t<div><\/div>\r\n\t<\/div>\r\n\t<\/div>\t<div class=\"w-grid-json hidden\" onclick='return {&quot;action&quot;:&quot;us_ajax_grid&quot;,&quot;infinite_scroll&quot;:0,&quot;max_num_pages&quot;:1,&quot;pagination&quot;:&quot;none&quot;,&quot;template_vars&quot;:{&quot;columns&quot;:&quot;1&quot;,&quot;exclude_items&quot;:&quot;none&quot;,&quot;img_size&quot;:&quot;default&quot;,&quot;ignore_items_size&quot;:0,&quot;items_layout&quot;:&quot;13413&quot;,&quot;items_offset&quot;:&quot;1&quot;,&quot;load_animation&quot;:&quot;none&quot;,&quot;overriding_link&quot;:&quot;%7B%22url%22%3A%22%22%7D&quot;,&quot;post_id&quot;:0,&quot;query_args&quot;:{&quot;ignore_sticky_posts&quot;:1,&quot;post_type&quot;:&quot;any&quot;,&quot;post__in&quot;:[&quot;13707&quot;],&quot;posts_per_page&quot;:&quot;10&quot;},&quot;orderby_query_args&quot;:{&quot;orderby&quot;:{&quot;date&quot;:&quot;DESC&quot;}},&quot;type&quot;:&quot;grid&quot;,&quot;us_grid_post_type&quot;:&quot;ids&quot;,&quot;us_grid_ajax_index&quot;:5,&quot;us_grid_filter_params&quot;:[],&quot;us_grid_index&quot;:5,&quot;page_args&quot;:[],&quot;lang&quot;:&quot;en&quot;}}'><\/div>\r\n\t<\/div><\/div><\/div><\/div><div class=\"vc_col-sm-6 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-grid type_grid layout_13413\" id=\"us_grid_6\" style=\"--gap:1.5rem;\"><div class=\"w-grid-list\">\t<article class=\"w-grid-item size_1x1 post-14186 post type-post status-publish format-standard hentry category-unkategorisiert\" data-id=\"14186\">\r\n\t\t<div class=\"w-grid-item-h\">\r\n\t\t\t\t\t\t<div class=\"w-vwrapper usg_vwrapper_1 align_none valign_top\"><div class=\"w-post-elm post_content usg_post_content_1\"><section class=\"l-section wpb_row height_auto width_full\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-6 vc_hidden-md vc_hidden-sm vc_hidden-xs wpb_column vc_column_container has_bg_color\" id=\"gradientrechts\"><div class=\"vc_column-inner us_custom_b38a3ea3\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(-90deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-6 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_870fb40f\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row hide_on_default via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container gradientunten has_bg_color\"><div class=\"vc_column-inner us_custom_63f60c5d\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(360deg, rgba(255,255,255,1) 3%, rgba(255,255,255,0.89) 20%, rgba(255,255,255,0.59) 42%, rgba(255,255,255,0.07) 62%, rgba(255,255,255,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><div class=\"wpb_text_column us_custom_3090c82c\"><div class=\"wpb_wrapper\"><h4><span style=\"color: #18add9;\">6.<\/span> BIOCOMPATIBILITY DOCUMENTATION<\/h4>\n<\/div><\/div><div class=\"wpb_text_column us_custom_26060442\"><div class=\"wpb_wrapper\"><p>If It Wasn&#8217;t Documented, It Didn&#8217;t Happen \u2026 ?<\/p>\n<\/div><\/div><div class=\"w-popup w-btn-wrapper align_none\"><button aria-label=\"Read more\" class=\"w-popup-trigger type_btn w-btn us-btn-style_59 icon_atright\"><span class=\"w-btn-label\">Read more<\/span><i class=\"fal fa-long-arrow-right\"><\/i><\/button><div class=\"w-popup-overlay\" style=\"background:rgba(0,0,0,0.25);\"><\/div><div class=\"w-popup-wrap layout_right_panel\" style=\"--title-color:var(--color-content-heading);--title-bg-color:var(--color-content-bg-alt);--content-color:;--content-bg-color:var(--color-content-bg);--popup-width:800px;--popup-padding:0px;\"><div class=\"w-popup-box animation_slideRight closerpos_inside without_title\"><div class=\"w-popup-box-h\"><div class=\"w-popup-box-content\"><section class=\"l-section wpb_row height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator size_medium\"><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_07960d64\"><div class=\"wpb_wrapper\"><h3>BIOCOMPATIBILITY DOCUMENTATION<\/h3>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>If It Wasn&#8217;t Documented, It Didn&#8217;t Happen \u2026 ?<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-image align_none\"><a ref=\"magnificPopup\" href=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/Bildschirmfoto-2024-06-16-um-13.58.01.png\" aria-label=\"Bildschirmfoto 2024-06-16 um 13.58.01\" class=\"w-image-h\"><img decoding=\"async\" width=\"1024\" height=\"258\" src=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/Bildschirmfoto-2024-06-16-um-13.58.01-1024x258.png\" class=\"attachment-large size-large\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/Bildschirmfoto-2024-06-16-um-13.58.01-1024x258.png 1024w, https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/Bildschirmfoto-2024-06-16-um-13.58.01-300x76.png 300w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/a><\/div><div class=\"wpb_text_column us_custom_f73f4019\"><div class=\"wpb_wrapper\"><p style=\"text-align: center;\">Click on the graphic to view it in full screen<\/p>\n<\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>The Biological Evaluation Plan (BEP) describes the strategy for investigating and ensuring the medical risk or biocompatibility of the medical device. The plan should describe and justify the biocompatibility assessment procedure in detail. All available information on the intended use of the device, the device configuration and design, the materials used in the device and in the manufacturing process, the production conditions and, if applicable, existing preclinical and clinical data should be taken into account.<\/p>\n<p>The biological evaluation plan will then identify the gaps in the biocompatibility assessment and, based on ISO 10993-1, provide an expert recommendation on how to close these gaps most efficiently.<\/p>\n<p>The development of a qualified biological assessment plan is expected by the authorizing institutions and authorities. In accordance with ISO 10993-1, it is also expected that all steps of the biocompatibility test in planning, execution, evaluation and documentation are carried out by experts.<\/p>\n<p>Finally, all data are compiled and evaluated by experts and summarized in the Biological Evaluation Report (BER). At the end, a qualified statement on biocompatibility and, if applicable, a biocompatibility certificate should be available as an important part of the authorization documents.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_medium\"><\/div><div class=\"w-separator size_medium\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><div class=\"w-popup-closer\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><\/div>\t\t<\/div>\r\n\t\t\t<\/article>\r\n<\/div><style id=\"grid-post-content-css\">.us_custom_37b2812c{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1418835107.jpg) 50% 50% \/ cover!important}.us_custom_870fb40f{text-align:inherit!important;margin-left:-3vw!important;margin-right:1.5rem!important;border-radius:1.5rem!important;position:relative!important;z-index:8!important;padding:3rem!important}.us_custom_e086fdbb{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1418835107.jpg) 50% 50% \/ cover!important}.us_custom_3090c82c{margin-bottom:10px!important}.us_custom_26060442{font-size:17px!important;line-height:1.6!important}.us_custom_005f1b5e{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1421547005.jpg) 50% 50% \/ cover!important}.us_custom_29547bd8{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1421547005.jpg) 50% 50% \/ cover!important}.us_custom_8e6a97a4{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1024119864.jpg) 50% 50% \/ cover!important}.us_custom_63e85b32{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1024119864.jpg) 50% 50% \/ cover!important}.us_custom_bfdda276{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1600739244.jpg) 50% 50% \/ cover!important}.us_custom_63f60c5d{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/04\/AdobeStock_403234519_Preview.jpeg) 50% 50% \/ cover!important}.us_custom_0c08878b{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1470913692.jpg) 50% 50% \/ cover!important}.us_custom_1728e0bc{min-height:210px!important;border-radius:1.3rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1470913692.jpg) 50% 50% \/ cover!important}.us_custom_b38a3ea3{min-height:390px!important;margin-left:1.5rem!important;margin-right:-3vw!important;border-radius:1.5rem!important;background:url(https:\/\/phatocon.com\/wp-content\/uploads\/2024\/06\/iStock-1465316259.jpg) 50% 50% \/ cover!important}@media (min-width:1001px) and (max-width:1150px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}@media (min-width:601px) and (max-width:1000px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}@media (max-width:600px){.us_custom_870fb40f{text-align:center!important;margin-left:0px!important;margin-right:0px!important;padding:0px 3rem 3rem 3rem!important}}<\/style><div class=\"w-grid-preloader\">\t<div class=\"g-preloader type_1\">\r\n\t\t<div><\/div>\r\n\t<\/div>\r\n\t<\/div>\t<div class=\"w-grid-json hidden\" onclick='return {&quot;action&quot;:&quot;us_ajax_grid&quot;,&quot;infinite_scroll&quot;:0,&quot;max_num_pages&quot;:1,&quot;pagination&quot;:&quot;none&quot;,&quot;template_vars&quot;:{&quot;columns&quot;:&quot;1&quot;,&quot;exclude_items&quot;:&quot;none&quot;,&quot;img_size&quot;:&quot;default&quot;,&quot;ignore_items_size&quot;:0,&quot;items_layout&quot;:&quot;13413&quot;,&quot;items_offset&quot;:&quot;1&quot;,&quot;load_animation&quot;:&quot;none&quot;,&quot;overriding_link&quot;:&quot;%7B%22url%22%3A%22%22%7D&quot;,&quot;post_id&quot;:0,&quot;query_args&quot;:{&quot;ignore_sticky_posts&quot;:1,&quot;post_type&quot;:&quot;any&quot;,&quot;post__in&quot;:[&quot;13709&quot;],&quot;posts_per_page&quot;:&quot;10&quot;},&quot;orderby_query_args&quot;:{&quot;orderby&quot;:{&quot;date&quot;:&quot;DESC&quot;}},&quot;type&quot;:&quot;grid&quot;,&quot;us_grid_post_type&quot;:&quot;ids&quot;,&quot;us_grid_ajax_index&quot;:6,&quot;us_grid_filter_params&quot;:[],&quot;us_grid_index&quot;:6,&quot;page_args&quot;:[],&quot;lang&quot;:&quot;en&quot;}}'><\/div>\r\n\t<\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_large\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row us_custom_a9be633b height_auto color_alternate\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_f70d789f us_animate_this\"><div class=\"wpb_wrapper\"><div class=\"w-separator size_large\"><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h2 style=\"text-align: center;\"><span class=\"gradient-text-dark\">Numbers<\/span> that speak for themselves<\/h2>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_medium\"><\/div><div class=\"g-cols wpb_row us_custom_eb849559 via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-4 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-counter us_custom_a236b2c1 color_primary align_center has_font_size\" data-duration=\"3\"><div class=\"w-counter-value\"><span class=\"w-counter-value-part type_text\" data-final=\"&gt; \">&gt; <\/span><span class=\"w-counter-value-part type_number\" data-final=\"15000\">0<\/span><span class=\"w-counter-value-part type_text\" data-final=\"\"><\/span><\/div><p class=\"w-counter-title\" style=\"font-size:16px;\">conducted approval-relevant studies under GLP\/GMP<\/p><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-4 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_fd89c19e\"><div class=\"wpb_wrapper\"><div class=\"w-separator hide_on_default hide_on_laptops hide_on_tablets size_custom\" style=\"height:3rem\"><\/div><div class=\"w-counter us_custom_a236b2c1 color_primary align_center has_font_size\" data-duration=\"2\"><div class=\"w-counter-value\"><span class=\"w-counter-value-part type_text\" data-final=\"\"><\/span><span class=\"w-counter-value-part type_number\" data-final=\"24\">1<\/span><span class=\"w-counter-value-part type_text\" data-final=\"\"><\/span><\/div><p class=\"w-counter-title\" style=\"font-size:16px;\">Years of industrial experience in applied toxicology<\/p><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-4 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator hide_on_default hide_on_laptops hide_on_tablets size_custom\" style=\"height:3rem\"><\/div><div class=\"w-counter us_custom_a236b2c1 color_primary align_center has_font_size\" data-duration=\"3\"><div class=\"w-counter-value\"><span class=\"w-counter-value-part type_text\" data-final=\"\"><\/span><span class=\"w-counter-value-part type_number\" data-final=\"0\">456<\/span><span class=\"w-counter-value-part type_text\" data-final=\"\"><\/span><\/div><p class=\"w-counter-title\" style=\"font-size:16px;\">Studies that were not accepted<\/p><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_large\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row us_custom_5fb9c346 height_auto color_alternate\" id=\"benefits\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-separator size_large\"><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h2 style=\"text-align: center;\">These are our <span class=\"gradient-text-dark\">values<\/span><\/h2>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_medium\"><\/div><div class=\"g-cols wpb_row us_custom_d51c81dc via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 vc_col-lg-4 vc_col-md-4 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-iconbox iconpos_top style_circle color_custom align_center\"><div class=\"w-iconbox-icon\" style=\"font-size:39px;--icon-color:#ffffff;--icon-bg-color:var(--color-content-link);\"><i class=\"fal fa-handshake-alt\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\">Integrity<\/h5><div class=\"w-iconbox-text\"><p>We do what we say. We say what we do.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator hide_on_default hide_on_laptops size_medium\"><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-4 vc_col-md-4 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_33cc52cd\"><div class=\"wpb_wrapper\"><div class=\"w-iconbox iconpos_top style_circle color_custom align_center\"><div class=\"w-iconbox-icon\" style=\"font-size:39px;--icon-color:var(--color-content-bg-alt);--icon-bg-color:var(--color-content-secondary);\"><i class=\"fal fa-user-plus\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\">Independence<\/h5><div class=\"w-iconbox-text\"><p>We allow ourselves to be remunerated but not bought<\/p>\n<\/div><\/div><\/div><div class=\"w-separator hide_on_default hide_on_laptops size_medium\"><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-4 vc_col-md-4 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-iconbox iconpos_top style_circle color_custom align_center\"><div class=\"w-iconbox-icon\" style=\"font-size:39px;--icon-color:#ffffff;--icon-bg-color:var(--color-content-link);\"><i class=\"fal fa-badge-check\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\">Quality<\/h5><div class=\"w-iconbox-text\"><p>Our work must be of verifiable quality for our customers.<\/p>\n<\/div><\/div><\/div><div class=\"w-separator hide_on_default hide_on_laptops size_medium\"><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator hide_on_tablets hide_on_mobiles size_small with_line width_default thick_1 style_solid color_border align_center\"><div class=\"w-separator-h\"><\/div><\/div><div class=\"g-cols wpb_row us_custom_d51c81dc via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 vc_col-lg-4 vc_col-md-4 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-iconbox iconpos_top style_circle color_custom align_center\"><div class=\"w-iconbox-icon\" style=\"font-size:39px;--icon-color:var(--color-content-bg-alt);--icon-bg-color:var(--color-content-secondary);\"><i class=\"fal fa-user-friends\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\">Respect<\/h5><div class=\"w-iconbox-text\"><p>We respect the (self-)responsibility of our fellow human beings<\/p>\n<\/div><\/div><\/div><div class=\"w-separator hide_on_default hide_on_laptops size_medium\"><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-4 vc_col-md-4 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_33cc52cd\"><div class=\"wpb_wrapper\"><div class=\"w-iconbox iconpos_top style_circle color_custom align_center\"><div class=\"w-iconbox-icon\" style=\"font-size:39px;--icon-color:#ffffff;--icon-bg-color:var(--color-content-link);\"><i class=\"fal fa-leaf\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\">Sustainability<\/h5><div class=\"w-iconbox-text\"><p>Our work also considers the requirements of tomorrow<\/p>\n<\/div><\/div><\/div><div class=\"w-separator hide_on_default hide_on_laptops size_medium\"><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-12 vc_col-lg-4 vc_col-md-4 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-iconbox iconpos_top style_circle color_custom align_center\"><div class=\"w-iconbox-icon\" style=\"font-size:39px;--icon-color:var(--color-content-bg-alt);--icon-bg-color:var(--color-content-secondary);\"><i class=\"fal fa-street-view\"><\/i><\/div><div class=\"w-iconbox-meta\"><h5 class=\"w-iconbox-title\">Freedom<\/h5><div class=\"w-iconbox-text\"><p>We despise all forms of oppression and exploitation<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-separator size_large\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row height_auto color_alternate\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><section class=\"l-section wpb_row height_auto width_full\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 vc_col-lg-6 vc_col-md-6 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_2fc23796 us_animate_this\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row hide_on_default hide_on_laptops via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container has_bg_color\"><div class=\"vc_column-inner us_custom_6484698f\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(360deg, rgba(8,43,79,1) 3%, rgba(8,43,79,0.89) 20%, rgba(8,43,79,0.59) 42%, rgba(8,43,79,0.07) 62%, rgba(8,43,79,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><div class=\"w-separator hide_on_tablets hide_on_mobiles size_medium\"><\/div><div class=\"w-separator hide_on_tablets hide_on_mobiles size_huge\"><\/div><div class=\"wpb_text_column gradient-text-dark\"><div class=\"wpb_wrapper\"><h6>CONTACT<\/h6>\n<\/div><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h1>Please feel free<br \/>\nto <span style=\"color: #18add9;\">contact<\/span> us!<\/h1>\n<\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Do you have any questions, a specific request or are you interested in our services? Then please feel free to contact us. Our team is available to you at any time by phone, e-mail or via our online form. We look forward to hearing from you and to supporting you!<\/p>\n<\/div><\/div><div class=\"w-separator size_small\"><\/div><div class=\"w-btn-wrapper align_none\"><a class=\"w-btn us-btn-style_32 icon_atright\" href=\"https:\/\/phatocon.com\/en\/contact\/\"><span class=\"w-btn-label\">Contact<\/span><i class=\"fal fa-long-arrow-right\"><\/i><\/a><\/div><div class=\"w-btn-wrapper align_none\"><a class=\"w-btn us-btn-style_60 icon_atright\" href=\"tel:08944489941\"><span class=\"w-btn-label\">+49 (0) 89 444 899 41<\/span><i class=\"fad fa-phone\"><\/i><\/a><\/div><div class=\"w-btn-wrapper align_none\"><a class=\"w-btn us-btn-style_60 icon_atright\" href=\"mailto:info@phatocon.com\"><span class=\"w-btn-label\">info@phatocon.com<\/span><i class=\"fad fa-envelope\"><\/i><\/a><\/div><div class=\"w-separator hide_on_tablets hide_on_mobiles size_medium\"><\/div><div class=\"w-separator size_huge\"><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-6 vc_hidden-sm vc_hidden-xs wpb_column vc_column_container  has_bg_color stretched\"><div class=\"vc_column-inner us_custom_94f5fdfc us_animate_this\"><div class=\"vc_column-overlay\" style=\"background:linear-gradient(90deg, rgba(8,43,79,1) 3%, rgba(8,43,79,0.89) 20%, rgba(8,43,79,0.59) 42%, rgba(8,43,79,0.07) 62%, rgba(8,43,79,0) 88%)\"><\/div><div class=\"wpb_wrapper\"><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div><\/div><\/div><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"6. BIOCOMPATIBILITY DOCUMENTATION If It Wasn&#8217;t Documented, It Didn&#8217;t Happen \u2026 ? Read moreBIOCOMPATIBILITY DOCUMENTATION If It Wasn&#8217;t Documented, It Didn&#8217;t Happen \u2026 ? Click on the graphic to view it in full screen The Biological Evaluation Plan (BEP) describes the strategy for investigating and ensuring the medical risk or biocompatibility of the medical device....","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-14084","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/pages\/14084","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/comments?post=14084"}],"version-history":[{"count":3,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/pages\/14084\/revisions"}],"predecessor-version":[{"id":14108,"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/pages\/14084\/revisions\/14108"}],"wp:attachment":[{"href":"https:\/\/phatocon.com\/en\/wp-json\/wp\/v2\/media?parent=14084"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}