Our hosts are joined this week by NAMSA colleagues, Dr. Sylvie Framery and Dr. Nicolas Martin  – LIVE from the NAMSA training series event in Frankfurt, Germany.  Sheri, Dr. Martin and Dr. Framery have spent the week conducting NAMSA’s biocompatibility training, and discuss the week’s events, the specific questions that seemed to drive the training this week, and any new awareness received from hearing attendee stories and experiences.

 “The MDR mentions that the manufacturer must demonstrate, amongst other things, the safety of its device but does not provide any technical solutions.. that’s why we will use the ISO 10993 series” – Sylvie Framery

“Regarding using post market data - We can always try… it depends on the quality of the data and device as well… we have to have more precise data to cover biocompatibility endpoints” – Nicolas Martin

“If we know the data are out there; to be in compliance with the standard we have to at least look at the data.“ – Don Pohl

“What’s the alternative… I’m not doing biocompatibility after 10 years and waiting 10 years” –  Sheri Krajewski-Bibins

Discussion points include:

• EU harmonization of 10993-1: 2018
• The Medical Device Regulation (MDR) and biocompatibility
• The use of post market surveillance
• How to prove biological safety for the “lifetime of the device”

Access NAMSA testing resources here at www2.namsa.com/MDR

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