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BiocompCHATibility Podcast
The biological evaluation plan and a manufacturers perspective, with guest Dave Parente of Ecolab.

The biological evaluation plan and a manufacturers perspective, with guest Dave Parente of Ecolab.

BiocompCHATibility vor 6 Jahren

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Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

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 Parente

Opinions 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/