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.
“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.
|Dr. Nicolas Martin; Principal Medical Research Scientist, NAMSA
Dr. Martin joined NAMSA in 2012. He holds an Engineer Degree in General Chemistry from École Supérieure de Chimie Physique Électronique de Lyon (France) and a PhD in Organic Chemistry from the University of Birmingham (UK). His expertise includes organic, analytical and industrial chemistry, and material and chemical characterization, with over 8 years research laboratory experience.
|Dr. Sylvie Framery; Semior Principal Biological Safety Scientist, NAMSA
Dr. Framery holds a Ph.D. in Biology. She has been working for more than 15 years with NAMSA, with experience primarily focused on the preclinical evaluation of medical devices. Based in the French NAMSA Laboratory, she serves as Subject Matter Expert in support of Medical Research Managers and Technical Advisors. She is the author of multiple documents including Biological Safety Plans, Biological Risk Assessments, Toxicological Risk Assessments, Gap Analyses and Expert Reports. She provides regularly training sessions in Europe to medical device manufacturers and Notified Bodies. She provides consulting services to manufacturers with biocompatibility projects for worldwide market approvals and supports them during on-site meetings with regulatory authorities. She is also an active member of the ISO/TC 194 committee.
|Sheri Krajewski-Bibins; Product Marketing Manager – Biological Safety, NAMSA
Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She 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, Sheri created the much sought-after NAMSA Training Series for the biological 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; Principal Product Development Strategist, NAMSA
Don holds a Bachelor’s degree from Ohio State University. He has over 25 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.