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Archives for March 2019

Medical Device Change Management Best Practices

Should you do a letter-to-file? It might allow you to make a change without notifying the FDA.

But having “avoid FDA notifications” as a motivating factor is a bad idea, says regulatory expert Michael Drues.

He said, “Several medical device companies tell their R&D engineers, “If you’re going to change a device, only change it to the point we can handle that change internally, doing a letter-to-file. Don’t change it to the point we have to notify the FDA.”

Can you think of any better way to prevent or hamstring development than putting a limitation on your R&D engineers?

Best Practices for Medical Device Change Management
Presented by Michael Drues and Jon Speer
at 10x for Design and Manufacturing – San Diego 2018


Click for the transcript. »

How To Use Human Factors To Mitigate User Risk

MaryBeth Privitera is impressive.

She co-chairs the AAMI human engineering committee, is the Human Factors and Research Principal for HS Design, and teaches biomedical engineering at University of Cincinnati.

Naturally, she gave an excellent talk at 10x in October, here for your education.

Managing the Big Risk – The User
presented October 11, 2018 by MaryBeth Privitera, PhD FIDSA


Click for the slides and transcript. »