Video: A Drop of DMR (Device Master Record)

This is part of an ongoing series of “droplet” videos intended to communicate key concepts in the medical device development process. Our hope is that these videos will create a higher level of dialogue and inherent understanding in our local, regional, and national innovation ecosystem.

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Gene Parunak
Flag It! FDA's New Guidance is Here to Streamline Things

Based on a successful pilot program, FDA, as of March 4th, 2019, has implemented a “least burdensome flag” program for the 510(k) clearance process. This program allows the submitter (within 60 days) to “throw a flag” on up to two areas in FDA’s response if they feel that the reviewers have not followed FDA’s least burdensome principles.

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Gene Parunak
Video: A Drop of Intended Use

This is the first in an ongoing series of “droplet” videos intended to communicate key concepts in the medical device development process. Our hope is that these videos will create a higher level of dialogue and inherent understanding in our local, regional, and national innovation ecosystem.

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Gene Parunak