NAMSA Training Series: Live from Frankfurt
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.