Come to Tech on the Edge!

Come out to Tech on the Edge, June 6th! We’re proud that the local ecosystem is expanding, and many thanks to Ann Arbor SPARK for recognizing and nurturing growth even if it’s not inside the city limits of Ann Arbor. Agenda linked below along with a nice article by SPARK’s own Phil Santer.

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Gene Parunak
Video: A Drop of 513(g)

This is part of an ongoing series of “droplet” videos intended to communicate key concepts in the medical device development process. "The 513(g) process is a way to get feedback from the FDA on your device classification. When you have an idea for a device but are unsure if it falls under the definition of a “medical device” or are not clear whether you’ve chosen the correct regulation for your device, the 513(g) process is a way to get an answer from the FDA on both these questions.

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Gene Parunak
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