Trusted Experience

Michael Wienholt, RAC (US; EU)

Founder & Principal Consultant


Michael has been employed in the medical device and vitro diagnostics industries for 25 years, including 15 years in regulatory affairs and quality systems management at Abbott Diagnostics, Guidant Endovascular, Ventana, Sequenom, and Accumetrics.


Michael holds regulatory affairs certification (RAC) in both United States and European Union regulatory affairs from the Regulatory Affairs Professionals Society (RAPS) and he is accredited by ANSI-RAB as a Lead Auditor for medical device quality systems.

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