Mike Billig’s 48+ year professional career has encompassed regulatory affairs, quality systems, clinical research, and general management for medical device companies. He has secured regulatory approval for hundreds of medical device products across the U.S., Europe, Canada, Central and South America, and Asia and is recognized as a regulatory expert for the medical device industry. Mike also has extensive experience in FDA’s growing areas of De Novo submissions and Breakthrough Device Designation and is particularly interested in supporting technologies for the important and underserved pediatric market.
Mike has led regulatory teams for a wide variety of technologies, including sterile disposable products, electronic instruments, robotics, combination products, mobile medical apps, and devices for regenerative medicine. Mike has particular expertise in interventional cardiology and cardiac surgery.