About Michael

Michael Wienholt, RAC

Owner & Principal Consultant


Michael has been working in FDA regulated industry for 32 years. The first 11 of these years were focused in research, product development, and chemistry manufacturing of in vitro diagnostics. The subsequent 21 years have been focused in regulatory affairs and quality management systems for both medical devices and diagnostics.

His early experience includes employment by global diagnostics and device manufacturers managing regulatory strategy, submissions and relationships with global health authorities and Notified Bodies, including the US Food and Drug Administration, MHRA and Health Canada. He has direct experience assisting manufacturers to achieve certification to ISO 13485, the international standard for quality systems for medical devices.

Michael earned his Bachelor of Science degree at North Carolina State University. He is regulatory affairs certified (RAC) in both United States and European Union regulatory affairs by the Regulatory Affairs Professionals Society (RAPS). He holds accreditation from ANSI-RAB for auditing of medical device quality systems. Michael enjoys the challenge of aligning the research, regulatory, quality, clinical and marketing plans with the shared goal of delivering to clinicians validated products that enhance patient care.