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Seminar 4: Selection, Testing and Validation of Medical Devices according to ISO 10993
10:00 AM

ISO 10993 Test requirements and how materials could impact biocompatibility testing

  • An overview of the most common biocompatibility tests and what materials could impact the results
  • How FDA and other regulatory agencies will interpret your results or test selection
  • How the new FDA Draft Guidance might impact your future testing
  • How to categorize your device according to ISO 10993

Thor Rollins B.S. RM (NRCM), Biocompatibility Expert, Nelson Labs

10:30 AM

Materials characterization for medical devices per ISO 10993-17,18

  • The correct way to extract your device to look for extractable and leachables
  • What tests to run to identify and quantify the compounds
  • How to determine the potential toxicological impact of the compounds

Thor Rollins B.S. RM (NRCM), Biocompatibility Expert, Nelson Labs

11:00 AM

What to do if you Fail a Biocompatibility Test

  • How to confirm the result
  • How to trouble shoot and ways to improve you device
  • How to justify a failure

Thor Rollins B.S. RM (NRCM), Biocompatibility Expert, Nelson Labs

11:30 AM

Q&A session


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