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Evaluation

Medical Devices

All in One for Biocompatibility: ISO 10993 Updates, Toxicological Risk Assessment and Post-market Data

Friday, May 16, 2025
10:30 - 11:30 CEST
Location: Gold Hall (level 0)
Learning Level: Intermediate
Description: In the dynamic field of biocompatibility evaluation, professionals must adeptly manage compliance across various markets while integrating post-market data and understanding toxicological risk assessment. This session will provide an overview of the latest regulatory challenges and strategies, providing an update of critical ISO 10993 changes that complete the transition of biological safety evaluation into a risk assessment process. We will also touch on biocompatibility submission pitfalls and examples of how to streamline documentation for global submissions. Last but not least, we will provide strategies for the integration of post-market data into biological evaluations. Participants will gain practical skills and insights to enhance device safety, streamline submission processes, and ensure compliance with evolving standards.

Learning Objectives:

  • Upon completion, participants will be knowledgeable about the recent updates to ISO 10993 and their implications for medical device development.
  • Upon completion, participants will be equipped with strategies to comply with Notified Body expectations as well as ideas to harmonize their documentation for global submissions.