We love start-ups!

We specialize in helping start-up medical device companies get their first product to market and to implement their first quality system.

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Learn how to obtain regulatory approval for your medical device and implement your quality system

Our training materials are updated for ISO 13485:2016, MDSAP, 21 CFR 820, and Regulation (EU) 2017/745

Rob Packard, President of Medical Device Academy
Rob Packard, President/Founder

Our training materials are designed for start-up medical device companies that are launching their first medical device product. We focus on compliance with the US, Canadian, and European market regulations.

Rob Packard has been teaching medical device quality system regulations for nearly 20 years, and his first regulatory submissions were in 2005. He was also a lead instructor for BSI from 2009-2012. Mary Vater, Sharon Morrow, and Matthew Walker are experienced consultants that help start-up clients with regulatory and quality system requirements every day.