Register to ISO 10993-1 Free Live Webinar
The New ISO 10993-1: Copernican Changes in Biological Evaluation of Medical Devices.
Format: Free live Webinar
Trainer: Dr. ssa Claudia Cusan – Registered Toxicologist
Date: 11th of November 2025
Time: 3:00 PM – CEST
Duration: 40 minutes + Q&A
Description: ISO 10993-1, the cornerstone standard for the biological evaluation of medical devices, is undergoing a major revision. Join this focused webinar to discover the most significant changes introduced in the upcoming edition and understand what these new requirements mean for medical device safety, biocompatibility strategy, and regulatory compliance.
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UPCOMING WEBINARS
Key Topics:
- Major differences between ISO 10993-1:2018 and the new draft revision
- The shift to a risk-based framework and integration with ISO 14971 principles
- Reorganized tables and updated device contact categorizations
- New requirements for risk estimation, biological hazard identification, and clinical relevance
- The end of prescriptive testing and implications for chemical characterization and genotoxicity assessment
- What these changes mean for your biological evaluation reports (BERs) and regulatory pathways
About Trainer Claudia Cusan, PhD – Toxicologist
Claudia Cusan is a Toxicologist Registered in Europe, with a PhD in Pharmaceutical science and 20 years relevant industrial experience, of which last five years fully dedicated in consultancy in toxicology, covering different competence areas, as medical devices, pharmaceutical products, chemicals, cosmetic formulations and materials in contact with food. She is active in performing pre-clinical evaluation of medical devices from class I to III, preparation of BEP, BER and Toxicological Risk Assessment of extractable, for MDR and FDA submissions. She gives training on different ISO standards and relevant topics related to biocompatibility
Who Should Attend:
- Regulatory Affairs Professionals
- R&D and Quality Teams
- Biocompatibility Specialists
- Medical Device Manufacturers and Consultants
Why Attend?
Grasp the “Copernican revolution” in biological evaluation requirements. Learn how to adapt your documentation, testing, and submission strategies to align with the new standard and stay ahead of evolving global compliance expectations.
