Overview

Gender

male

His entire 40+ year professional career has been involved with regulatory affairs, quality systems, clinical research, and general management for medical device companies. Mike has secured regulatory approval for hundreds of medical device products across the U.S., Europe, Canada, Central and South America, and Asia. He is a recognized industry expert in the growing area of FDA De Novo submissions. 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.

At Experien Group, Mike’s primary role for client companies is to provide strategic regulatory and clinical support, including virtual staff executive leadership. For several clients, Mike functions as the Acting Vice President of Regulatory, Quality and Clinical, representing the companies in Board of Directors meetings, sales meetings, industry symposia, investors meetings, regulatory agency interface, and more. Mike assists small start-ups, mid-sized companies and major public corporations alike, providing advisory and tactical direction for:

Complex U.S. and international regulatory and clinical strategies
Communications and interface with U.S. and international regulatory agencies
U.S. and international regulatory submissions
Venture presentations and facilitation of strategic corporate partnerships
FDA and international compliance activities (e.g., MDRs, Vigilance Reporting, and field actions)
Product labeling and promotional materials