Profile

Username

akomiyama_bluestocking.health

First Name

Allison

Last Name

Komiyama

Title

CEO

Location

San Diego, CA, USA

Company Name

Bluestocking Health, LLC

Professional Bio/Service Description

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 was focused on digital therapeutics, monitoring devices, smart orthopedic devices, wearable technology, pediatric devices, and neurostimulators with unique indications. She recently started a medical device hype company called Bluestocking Health, where she continues to elevate and amplify the message of exciting technologies entering the market.

Your Website

http://www.bluestocking.health

LinkedIn URL

http://www.linkedin.com/in/allisonkomiyama

Languages

English

Expertise

Service Provided

Consulting

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