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As the foundation of biological evaluation for medical devices, ISO 10993-1 plays a vital role in ensuring patient safety and regulatory compliance. With the latest revisions to the standard, it’s essential for stakeholders across the medical device lifecycle to stay ahead of the curve. 

Join us for this free, informative session where we unpack the significant changes, explore the rationale behind the updates, and examine the practical implications for industry professionals involved in medical device design, testing, and regulation.

What the webinar will cover:

  • An overview of the most significant updates to ISO 10993-1.
  • The regulatory and safety rationale behind the changes.
  • Anticipated industry challenges and practical ways to address them.
  •  Clarification of new requirements and their implications for manufacturers, test labs, and regulatory affairs professionally.
  • Live Q&A session to address audience concerns and questions.

Webinar details:

Date: Wednesday 3rd December 2025
Time: 12:00–13:00pm (GMT) 
Location: Online

Agenda

12:00 – 12:05pm: Introduction and welcome, Lindsey Ferrari, BSI


12:05 – 12:15pm: Key changes in BS EN ISO 10993-1 revision with: Michelle Kelly, Toxicologist, Namsa and Sophie Clewlow, Leading Senior Biological Safety Assessor.


12:15 – 12:55pm: Q&A Roundtable Discussion, all speakers, moderated by Lindsey Ferrari, BSI


11:55 – 13:00pm:Closing Remarks, Lindsey Ferrari, BSI

 

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