Michael has worked in Research and Development world since 1991. He has worked for several diverse companies with specialties ranging from environmental services to the medical industry. His experience in the medical field spans 20 years with a specialized understanding of the interventional segment. Over his 25 year career, Michael has been issued 70 US and foreign patents with 50 applications still pending. He has specialized in creating and recording intellectual property for a variety of devices. He has been considered a creative power house with keen problem solving abilities that has led to many successful novel products which have earned his employers over a billion dollars.
- 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)