Kevin M.
Medical Device Compliance - FDA Regulatory, ISO 13485, ISO 62304
Greetings. I have a wide background in healthcare compliance. My areas of expertise include... the commercialization of medical devices, and FDA 510k submissions. I also offer expertise to device manufacturers about ISO requirements including ISO 13485 (medical devices), ISO 62304 (Software Development), ISO 14971 (Risk Management), and ISO 22301 (IT Business Continuity). Finally, I provide HIPAA compliance services to licensed healthcare Providers and Business Associates. I'm certified as Lead Auditor for ISO13485, and I’ve helped many device manufacturers achieve and maintain ISO Certification. My Clients have included established device manufacturers, software developers, entrepreneurs, and many healthcare Providers. I've held staff & mgmt positions w large Fortune 100 corporations and worked with many start-ups/ early-stage companies. I have BA/MA degrees from American universities, and I'm a Member of Regulatory Affairs Professional Society (RAPS). Native English speaker. I'm happy to discuss your Project, and I'm avail during normal business hours, CDT. Pls refer to my website for more: medtechresults.com
Earnings and projects
Last 6 months ÷ 6
Billed in all: $90,414$90k
$0 in the last 6 months
Across 78 contracts