Smart Choices in your Biocompatibility Evaluation Process

Focus on Common Challenges and the Role of Chemical Characterization


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
Net price

€ 49.00

Overview of covered topics

Purpose of the webinar

Participants will be able to:

Who should attend

Basic knowledge required

Presenting experts

Muna Kebede

Senior Consultant

Dr. Anna Spehl

Senior Consultant

Attilio Durantini

Advisor for Medical Devices testing
PH Labs / TÜV SÜD Group

Elena Ciofi

Technical Director of Laboratory
PH Labs / TÜV SÜD Group

Rachele Nardella

Technical Sales - Biocompatibility of Medical Devices
PH Labs / TÜV SÜD Group

Dr. Anna Spehl

Senior Consultant

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