The event provides a short overview of the biological evaluation of medical devices within a risk management process including and highlighting, where appropriate, the aspects related to the work with the relevant laboratory. Senior regulatory professionals of AKRA TEAM will mainly address the challenges numerous manufacturers face in either updating, maintaining, and or establishing the biocompatibility evaluation of their devices and/ or products. The technical director of PH Labs TÜV SÜD will share an insightful overview of the best practices in the chemical characterization process, giving technical details such as: extraction conditions, calculation of AET, and how to determine the appropriate test methods and parameters. The event highlights several smart choices the manufacturer can make in its strategic steps towards achieving full compliance with the relevant normative and regulative requirements, whilst also avoiding loss of time and resources along the way. The relevant requirements addressed will be:

• ISO 10993-1 and other endpoint relevant standards from the ISO 10993 series, as well as its integration in the risk management framework ISO 14971 within the QMS (ISO 13485)
• Regulation (EU) 2017/745