Allison Komiyama PhD

Allison Komiyama PhD

President, AckRS
RQM+

Categories covered by Allison

Talks covered by this speaker

30

FDA Today - EUA & SaMD

About this Speaker

Allison is a regulatory consultant focused on FDA submissions for the medical device industry. Throughout her career, she has been actively involved in hundreds of pre-submissions and premarket submissions for a wide array of medical device companies. Her previous company (AcKnowledge Regulatory Strategies, LLC) that she founded in 2014 was purchased by RQM+ in late 2021. At RQM+, she and her team continue to work with small to large medical device companies as they now support all device types during the entire product life cycle. Much of her recent work has been focused on digital therapeutics, monitoring devices, smart orthopedic devices, wearable technology, pediatric devices, and neurostimulators with unique indications. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about Regulatory Submissions as a faculty member at UCSD extension. She was an FDA reviewer for a brief stint from 2010-2011 and received her Regulatory Affairs Certification (US) in 2014.   

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