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Repeat Solutions Circle
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Allison Komiyama, PhD, RAC, FRAPS

Vice President, MedTech Innovations
RQM+

Allison Komiyama is a regulatory consultant focused on FDA submissions for the medical device industry. She received her PhD in Neuroscience from Stanford University and her bachelor’s degree in molecular and cell biology from the University of California, Berkeley. 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 and diagnostics, 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 SDSU Global Campus. She was an FDA reviewer for a brief stint from 2010-2011, received her Regulatory Affairs Certification (US) in 2014, and became a RAPS Fellow in 2024.

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