Allison Komiyama, Ph.D, RAC, FRAPS

Board Member – indieMedTech
Founder – Bluestocking Health LLC
Allison Komiyama

Allison is a consultant focused on getting medical devices to market and helping them stay there! 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 received her doctorate in neuroscience in 2009, was an FDA reviewer from 2010-2011, received her Regulatory Affairs Certification (US) in 2014, and became a RAPS Fellow in 2024.

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 worked with small to large medical device companies to support all device types during the product life cycle. Much of her work has been focused on digital therapeutics, monitoring devices, smart orthopedic devices, wearable technology, pediatric devices, and neurostimulators with unique indications. She recently started a company called Bluestocking Health, where she continues to elevate and amplify the message of exciting technologies entering the market.

Niki Caporali Spaniel
Co-Founder – IndieMedTech
Sr. Consultant – CMD MedTech
Founder – Sol MedTech
Picture1
Co-Founder – IndieMedTech
Founder and Principal Consultant – White Lamb Consulting
Theresa Miles
Board Member – indieMedTech
CEO – MedDevice Growth Solutions LLC
Allison Komiyama
Board Member – indieMedTech
Founder – Bluestocking Health LLC
Amie Smirthwaite
Board Member – indieMedTech
Independent Consultant
Daria Brown
Board Member – indieMedTech
Regulatory Affairs Professional
Michelle Mahoney
Board Member – indieMedTech
Quality & Regulatory Strategist – MedTech Growth Partner
Catherine Kang
Board Member – indieMedTech
Founder, CEO, and Primary Consultant – MedTegrity RQ LLC
Melissa DeHass
Board Member – indieMedTech
Director, Regulatory – MEDIcept
felicia-hosey
Board Member – indieMedTech
Managing Director - MDDX Solutions LLC

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