Chemistry with the MFDS

BiocompCHATibility vor 2 Jahren

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35:10

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

In this episode, our hosts are joined by Charles Ducker, PhD
(NAMSA's Senior Director of Analytical Services) who recently
returned from Korea, where he provided training to the MFDS
(Ministry of Food and Drug Safety) about ISO 10993-18. Throughout
this discussion, we review the use of the standard and how it is
adopted by Korean authorities. We also explore the challenges
that lie ahead for device developers and testing labs.

“I think they [MFDS] were maybe surprised at the complexity.
Laying out the information you have on your materials and the
knowledge that you already have that may not lead to doing
testing.” – Dr. Charles Ducker

“They were interested in how to apply ISO 10993-1 and how you
apply ISO 10993-18 to the standard. And they want to know how to
assess whether a laboratory has conducted the test
appropriately.” – Dr. Charles Ducker

“One of the things I thought was very interesting… around Part
18, was what is different now versus the outdated version, and
what changes came about. We had a lot of discussion about what is
required and one of the big ones was AET [Analytical Evaluation
Threshold] and how we calculate it.” – Dr. Charles Ducker

“Also, about how we qualify methods, what components go into that
and what data you have to have behind the scenes to support the
fact that your methods are appropriate for the intended use.” –
Dr. Charles Ducker

Topics include:

Korea’s current position with the use of ISO 10993-18

Qualification of a laboratory for chemical characterization
testing

Solvents and temperatures, and the justifications for each