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The Biological Evaluation Plan: A Manufacturer’s Perspective with Guest Dave Parente of Ecolab


Our hosts are joined this week by David Parente, Director of Global Sterilization and Biological Safety at Ecolab. During this episode, the team discusses Dave’s chapters in the new book, Biocompatibility and Performance of Medical Devices. Mr. Parente has a long history with the Biological Evaluation process, including the foundation of NAMSA’s first Biological Safety Consulting Team, NAMSA Advisory Services. For many years, he has taught and wrote about the importance of Biological Evaluation Plans, which are informed by his experience as a manufacturer facing regulatory challenges surrounding Biological Evaluation expectations.

“It all speaks to the importance of a plan—plan, evaluate, plan, evaluate. Things change and you have to do this continually.” – Don Pohl

“Every device does not fit on this table.”  Sheri Krajewski-Bibins

“If you truly understand the risks your device introduces with its intended use, that’s an active means in evaluating biocompatibility.” – Dave Parente

“As a segue to the 2018 version of 10993-1 and its greater emphasis on one of the aspects of biocompatibility, manufacturing affects the safety of a device.” – Don Pohl

“Originally, everyone just said this is a checklist […] and credit to TC 194, they have slowly over the past 10 years or so transformed biocomp to what it should be—its risk assessment. There are several degrees of risk […] If I have to mitigate this risk, then what’s my plan for mitigation?” – Dave Parente

Connect with Dave here https://www.linkedin.com/in/davidmparente/

Also be sure to check out our Biocompatibility Strategy Navigator.