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MedTech Summit
Hybrid Event, 20 - 24 June 2022
In-Person: Clayton Hotel Burlington Road, Dublin, IrelandDigital Experience: One track will be live-streamed each day in BST time zone, with on-demand recording access for all other tracks made available from Monday 27th June. Learn more on the Digital Experience page.

Hybrid Event, 20 - 24 June 2022
In-Person: Clayton Hotel Burlington Road, Dublin, Ireland,
Digital Experience: One track will be live-streamed each day in BST time zone, with on-demand recording access for all other tracks made available from Monday 27th June. Learn more on the Digital Experience page.

ISO 10993: Stay Ahead Of The Latest Revisions and Best Practice

Biocompatibility testing and evaluations requirements: Feedback from TC 194 Working Group, Competent Authority, Notified Body and industry experts

Including ISO 10993-1 updates, part 17 insights, part 23 applications, implementation timelines, risk assessments, chemical characterisation, extractables and leachables, and more!

Implement Biological Evaluation Plans For Your Medical Devices With Confidence

ISO 10993 Updates And Guidance

  • How will the recent part 1 revision impact your biocompatibility testing, evaluations and risk assessments? Ensure you’re prepared with expert guidance
  • Practical advice for applying part 18 for chemical characterisation of extractables and leachables, analytical techniques, and common pitfalls
  • Get to grips with the recent part 17 updates for the establishment of allowable limits for leachable substances
  • Experiences with adapting to the complexities of the new part 23 standard for irritation testing

Address Your Biocompatibility Questions In Interactive Panel Discussions

  • What is the future of in vitro testing? Leading perspectives on what’s possible and insights on acceptance of ISO 10993-23, tests for irritation from Urbilateria Conseil, Medtronic, TÜV SÜD
  • Discuss the challenges of toxicological risk assessments with Zimmer Biomet and more
  • ISO 10993-1 revision: Addressing the challenges, impact and future concerns with TÜV SÜD, Zimmer Biomet and the convenor of ISO TC121/SC3/WG13

Global Biocompatibility Challenges Addressed

  • Biocompatibility testing and reporting: Get to grips with Competent Authority expectations in Europe with feedback from FAGG - AFMPS
  • NMPA keynote: Biocompatibility testing in China
  • Panel discussion: Understand the interpretations of ISO 10993 standards in Asia-Pacific and how to address the challenges

Mollie J. Holter

Consultant & Owner

MicroBio Consulting, LLC

“As a speaker new to the event, I found this a high quality conference with the right audience. The attendees were well educated asking good questions and demonstrated a good baseline knowledge of biocompatibility.”