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BiocompCHATibility Podcast
Finding the Qualified Biocompatibility Unicorn

Finding the Qualified Biocompatibility Unicorn

BiocompCHATibility vor 6 Jahren

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40:42

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

In this episode, our hosts are joined by Nicole Soucy, PhD, DABT
from Boston Scientific to discuss qualifications of expert
assessors and other personnel qualified to make biological
evaluation decisions for medical devices. Documents including ISO
10993-1, Medical Device Regulation (MDR) documentation
submissions and BSI best practice guidelines recommend having a
qualified individual make decisions for the biocompatibility of
medical devices.

While many testing organizations claim to perform this work, what
does “qualified” really mean and how do companies determine this
qualification?

In this episode, our experts discuss hiring and training
processes utilized to identify and grow qualified individuals
within their organizations.

“What are the qualifications that a person needs to have to
evaluate the biocompatibility of a device? We get questioned
about it all the time.” –Don Pohl

“Anytime you have a position open…you’re looking for that needle
in a haystack to find someone who is appropriately qualified and
has a good, strong background.” -Nicole Soucy

“You are not going to go out and find someone who has a
Bachelor’s or Master’s degree—or even a PhD—in medical device
biocompatibility; those people don’t exist. There is definitely
an on-the-job training component to growing and developing this
skill set.” -Nicole Soucy

“A really critical partner in all of this is your analytical
chemist. They need to be integrated into you team. You need to
have strong chemistry support all the way through your project.”
-Nicole Soucy

Discussion points include:

How this role is the “famed unicorn” of medical device
development

How on-the-job training is a critical component to successful
assessors

How long until an assessor is able to work independently on a
plan and assessment

Challenges with regulators utilizing an assessment properly

What someone looks for when choosing a qualified individual
to perform this work

*Please note that the opinions discussed throughout the
podcast are their own and do not reflect that of their current or
former employers.