Wonderful World of Biocompatibility. Recent Updates and Challenges
This presentation provides a practical overview of the key updates in the revised ISO 10993‑1 standard and their impact on the biological evaluation of medical devices.
It focuses on the new categorization of medical devices and the strengthened, lifecycle‑based risk management approach. Participants will gain a concise yet comprehensive understanding of how this standard influences the risk management process, testing requirements, and regulatory expectations in their daily work environment.
Please note: the presentation will be held in German.
Speakers (1)
Kristin Rödig
Consultant / Deputy Head of Consulting, Eurofins BioPharma Consulting Services Munich GmbH
