Mike has over 35 years of experience in the medical device industry with emphasis in regulatory affairs. He has experience in medical device development in Class I, II and III products including IDE, PMA, 510(k), CE Mark and other international registrations. His background includes experience in product development including regulatory, research, pre-clinical, and quality. Mike also has experience in customer relationships, negotiation, strategic regulatory planning, divestment and integration.
- Final FDA guidance explains how the agency evaluates benefit and risk issues in Investigational Device Exemptions (IDE) for medical devices that require clinical trials in order to be registered.
- Final US FDA Guidance on Post-market Cybersecurity Risk Management
- ISO 13485:3026
- Due Diligence and QMS assistance
- Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)