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MedTech Summit US

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December 6 - 8, 2022
Intercontinental Chicago Magnificent MileChicago, IL

ISO 10993: Are You In Line with the Latest Revisions and Best Practices?

Immerse Yourself in the Discussion with Keynote Sessions, Case Studies, and Panels Compiled from the FDA, TC 194, Notified Bodies and Medical Device Pioneers

Spotlight on ISO 10993-1 &-12 revisions, part 17 & 18 insights, part 23 applications, implementation timelines, risk assessments, chemical characterisation, and more!

Implement Biological Evaluation Plans For Your Medical Devices With Confidence

ISO 10993 Updates as They Happen

  • Practical applications on -18 from Abbott
  • Discussion on revisions to -17 and regulatory expectations by Risk Science Consortium
  • Panel discussion on navigating chemical characterization and toxicological risk assessment concerns

The Future of In Vitro Testing

  • The status of FDA’s opinion on in vitro with Jennifer Goode
  • Case study examples of implementing in vitro with Medtronic and MatTek Life Sciences
  • Panel discussion on the future of in vitro with FDA, Medtronic and Boston Scientific

Best Practices for ISO Compliance

  • Industry panel on ensuring MDR compliance with Straumann Group, Abbott and Boston Scientific
  • Reflections on biological evaluation report creation with ConvaTec
  • Documenting revisions to -12 with Terumo Medical