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BiocompCHATibility Podcast
Welcome to the RA QA Café

Welcome to the RA QA Café

BiocompCHATibility vor 3 Jahren

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Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

In this first BiocompCHATibility Podcast episode of 2023, our
hosts are happy to introduce

a new podcast to the NAMSA family, and talk a little bit to the
hosts about the insightful

topics to come.

This new, conversational podcast will feature a new set of hosts
who dedicate each

episode to trending regulatory and quality affairs topics within
the MedTech industry.

Future topics include:

Refuse to Accept Policy for 510(k)s – This episode will delve
into the procedures

and criteria FDA intends to use in assessing whether a premarket
notification

(510(k)) submission meets a minimum threshold of acceptability
and if it should

be accepted for substantive review.

FDA Releases Draft Guidance: Content of Premarket Submissions
for Device

Software Functions – As a follow-up to one of NAMSA’s recent blog
posts, our

hosts will describe information that the FDA deems important
during its

evaluation of the safety and effectiveness of device software
with one or more

device functions.

Compliance Pitfalls (Start-up Focus) – This episode will
focus on common

compliance obstacles faced when dealing with documenting
procedures,

complaint handling processes, supplier controls, audit &
training, laboratory

controls, monitoring and calibration and more.