Dr. Sylvie Framery, Senior principal medical research scientist at NAMSA, has 16 years of work experience primarily focused on the pre-clinical evaluation of medical devices. In the French NAMSA Laboratory, she serves as Technical Specialist in support of Medical Research Managers and Project Development Advisors. She is the author of multiple documents including Biological Safety Evaluation Plans, Biological Risk Assessments, Toxicological Risk Assessments, Gap Analyses, Expert Reports and Clinical Evaluations via the literature route as well. Member of ISO/TC 194 committee, she provides consulting services to manufacturers with biocompatibility projects to support worldwide market approvals. She also provides regularly training sessions in Europe to medical devices manufacturers and Notified Bodies and oral presentations at trade shows on Medical Devices in Europe and China.