Startseite
Podcasts
BiocompCHATibility Podcast
NAMSA Training Series, Live from Frankfurt Germany

NAMSA Training Series, Live from Frankfurt Germany

BiocompCHATibility vor 6 Jahren

0:00

30:02

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

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

Opinions are their own and do not reflect that of their current
or former employers.