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BiocompCHATibility Podcast
Listener Mail Bag – We Answer Your Questions

Listener Mail Bag – We Answer Your Questions

BiocompCHATibility vor 6 Jahren

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33:58

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

In this episode, our hosts answer your questions about
biocompatibility. After 15 episodes of discussing what we think
is important surrounding this topic, we asked for your questions
and created this special episode to answer them.

“A toxicological risk assessment is the process of focusing on
the risk associated with the chemicals that are in or may come
out of a device, that’s your primary focus.” –Don Pohl

“The first step to investigation is trying to understand root
cause […] what went into to my device that might cause this
response.” - Don Pohl

“I love the ever changing environment, and I’m excited about us
(the industry) getting better at performing evaluations that
minimize unnecessary testing,” – Sheri Krajewski-Bibins

“The reality is, if you look at the grand scheme of things, it
(biological evaluation of medical devices) is relatively new in
terms of what we are doing – it’s constantly evolving and
changing.” - Don Pohl

Discussion points include:

Updates on In Vitro alternative testing

How to handle unexpected biocompatibility results

What genotoxicity methods are preferred by the FDA

Alternative extraction temperatures accepted by the FDA

Differences between a toxicological risk assessment and a
biological risk assessment

The future of biological safety evaluations – an exciting
outlook