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ESC Boston 2019 Schedule Viewer


Welcome to the Biomed Boston & ESC Boston 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

How Changing Regulations Will Impact Your Biocompatibility Testing & Submission Process

Matthew Jorgensen  (Chemistry and Materials Scientist, Nelson Laboratories, LLC)

Beau Rollins  (Director, Quality Services, Convatec)

Location: 160B

Date: Wednesday, May 15

Time: 2:00 pm - 2:45 pm

Track: BIOMEDevice Boston, Track B: Research & Development

Vault Recording: TBD

With the changes to the ISO 10993 series and to the EU Medical Device Regulations, biocompatibility evaluations have entered a whole new realm. No longer will “check box” testing be allowed, and justifications are needed for not just omitting tests, but also for what testing is needed.

Topics covered include:
  • Chemical compatibility of materials for both medical and IVD devices
  • Examples demonstrating approaches to make the regulatory process easier
  • Best practices on how to implement these changes