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BiocompCHATibility Podcast
What Exactly is my Test Article?

What Exactly is my Test Article?

BiocompCHATibility vor 4 Jahren

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32:32

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

In this episode, Dr. Phil Smiraldo (NAMSA’s Senior Toxicologist)
joins us to discuss the test article and the many challenges with
identification and preparation. Throughout this discussion, we
explore the many different types of test articles and help define
what is considered patient contact and what is not? We also
review how you can best work with your laboratory to define your
test article preparation and make certain the test article
definition is clear to the regulatory agency

Listeners can expect to learn:

How to easily define their test article

Key points to consider when separating patient contacting and
non-patient contacting devices

The risks of including non-patient contacting components in
an extract

“One of the things we thought we’d elaborate on today is how do I
define my test article.”

-Sheri Krajewski

“We are not going to jump into the GLP regulations and jump into
that definition, but we

will help define the test article as it relates to
biocompatibility.”– Don Pohl

“I’ve even worked through a scenario for a particular device
where the customer in fact

came onsite to help take it apart.” – Phil Smiraldo

“This stuff [prep instructions] needs to be written down clearly
so anyone can follow.” –

Don Pohl