Our hosts are joined this week by David Parente, Director of Global Sterilization at and Biological Safety at Ecolab.  During this episode the team discusses Dave’s chapters in the new book, Biocompatibility and Performance of Medical Devices.  Dave has a long history with the biological evaluation process, including founding NAMSA’s first biological safety consulting team, NAMSA Advisory Services.  For many years Dave has been teaching and writing about the importance of a plan.  Additionally, Dave has years of experience as a manufacturer facing the challenges of meeting biological evaluation expectations from regulators.“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 your truly understand the risks your device introduces udrin it’s intended use– that’s an active means in evaluating biocompatibility ” – Dave ParenteOpinions are their own and do not reflect that of their current or former employers. “As a segue to the 2018 version of 10993-1 and it’s greater emphasis on one of the aspects of biocompatibility – manufacturing effects on 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 – it’s 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/

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