Senior Advisor and Regulatory Consultant
Vapotherm develops solutions for respiratory airway therapies.
Medical Device executive who has led teams in achieving positive results, capitalizing on a diverse background and balanced approach, in demanding, high risk environments including life sustaining devices used in the home. Mike has spent over 20 years bringing products to market, from product development and validation, through manufacturing, to gaining U.S. and international regulatory approvals. Experience includes extensive interactions with FDA including multiple successful inspections, IDE clinical studies, and over thirty 510k's cleared.
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