NAMSA Training Series: Live from Frankfurt

Operating room with monitor

Published:

May 29, 2020

BiocompCHATibility

A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.

Our hosts are joined this week by NAMSA colleagues, Dr. Sylvie Framery (Senior Principal Biological Safety Scientist) and Dr. Nicolas Martin (Principal Medical Research Scientist)—LIVE from the NAMSA Biological Safety Training Series event in Frankfurt, Germany. In this episode, the team discusses the week’s events, including specific questions that drove the training and new lessons learned from hearing attendees’ stories and experiences.

Podcast Excerpts:

“The [Medical Device Regulation (MDR)] mentions that the manufacturer must demonstrate, amongst other things, the safety of their device but does not provide any technical solutions.. that’s why we will use the ISO 10993 series” – Dr. Sylvie Framery, Senior Principal Biological Safety Scientist

“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” – Dr. Nicolas Martin, Principal Medical Research Scientist

“If we know the data is out there, to be in compliance with the standard, we have to at least look at the data.“ – Don Pohl, Principal Product Development Strategist

“What’s the alternative? I’m not doing biocompatibility after ten years and waiting ten years” –  Sheri Krajewski-Bibins, Product Marketing Manger – Biological Safety

Discussion points include:

  • EU harmonization of 10993-1: 2018
  • MDR and biocompatibility
  • The use of Post-Market Surveillance
  • How to prove biological safety for the “lifetime of the device”

Also be sure to check out our Biocompatibility Strategy Navigator.

Sheri Krajewski

Sheri Krajewski

Sheri joined NAMSA in 2003 and currently serves as Senior Global Product Marketing Manager of Biological Safety. Sheri has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s Biological Safety Consulting business. Additionally, she created the much sought-after NAMSA Training Series (NTS) for the iological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.

Don Pohl

Don Pohl

Don Pohl is currently the Manager of Biological Safety & Validation at NAMSA. He holds a Bachelor’s degree from Ohio State University. Don has over 20 years of experience in the pre-clinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.

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