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Allison Komiyama

Allison is a former FDA med device reviewer with years of experience preparing submissions and offering regulatory strategy advice. She is a regular speaker for Enventure's Foundations course and a natural educator. AcKnowledge works with the FDA to get your device on the market with ease. AcKnowledge Regulatory Strategies specializes in Regulatory Affairs (RA) and Quality Assurance (QA) consulting exclusively for the medical device and In Vitro Diagnostic (IVD) industry. When you hire them, you also hire our entire network of current and former FDA reviewers, scientists, engineers, and regulatory/quality experts. They understand that each medical device needs a specific and tailored strategy to earn regulatory clearance. They strive to work with the FDA to ease the review process and get your device on the market faster than our competitors.