6. BIOCOMPATIBILITY DOCUMENTATION If It Wasn’t Documented, It Didn’t Happen … ? Read moreBIOCOMPATIBILITY DOCUMENTATION If It Wasn’t Documented, It…

5. QUALITY MANAGEMENT IN RESEARCH & DEVELOPMENT Tools for continuous improvement Read moreQUALITY MANAGEMENT IN RESEARCH AND DEVELOPMENT Tools for…

4. OUTSOURCING & PROJECT MANAGEMENT Identification of suitable contract research organisations (CROs) and competent study monitoring Read moreOUTSOURCING AND PROJECT…

3. BIOLOGICAL / TOXICOLOGICAL ENDPOINTS Identification of biological effects after exposure Read moreBIOLOGICAL/TOXICOLOGICAL ENDPOINTS Identification of biological effects after exposure…

2. TOXICOLOGICAL RISK ASSESSMENT Calculation of safety margins based on toxicity and concentration of identified extractables Read moreTOXICOLOGICAL RISK ASSESSMENT…

1. CHEMICAL CHARACTERIZATION Identification and quantification of extractables and leachables (E&L) Read moreChemical characterization Identification and quantification of extractables and…