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Biological Safety Evaluation:

Using a Risk-Based Approach for Biocompatibility

Nelson Labs hosted a half-day Seminar at MD&M East on June 12, 2019. The PDF of the presentation from this seminar is now available! Contact [email protected] for more information.

Presenter: Thor Rollins, Director, Toxicology & E&L Consulting, Nelson Labs, LLC

Part 1- ISO 10993-1 Biocompatibility (Applying the New ISO 10993 Standards)

  • An overview of the new ISO 10993-1
  • Performing a Biological Evaluation Plan
  • Overview of the “Big Three” including new in vitro alternatives
  • What is needed in a Biological Evaluation Report for the FDA?


Part 2- ISO 10993-18 What is E&L and How to Evaluate Changes to Medical Devices

  • What is the current regulatory status of extractable & leachable testing?
  • How can we make sure the regulatory bodies will accept our E&L studies?
  • If  a material is changed, how is safety impacted?
  • If the change is small, is do you need to retest?
  • What if I change a manufacturing process, do you need to retest?


Part 3- MDRs Riding out the Storm

  • What changes do the MDR bring and how much time do I have to comply?
  • Will Brexit impact my European submission?
  • What will my Notified Body be looking for with regard to the MDR?
  • Case study regarding different approaches