Michael Wienholt,
Managing Partner
RAC

My experience

Michael Wienholt has been working for the past 25 years in FDA regulated industry, first in research, product development, and chemistry manufacturing of IVDs, then in regulatory affairs and quality systems compliance for both medical devices and IVDs.

Michael holds certifications in both US and EU regulatory affairs issued by the Regulatory Affairs Professionals Society. His academic qualifications include a BSc from North Carolina State University and a Diploma from Baltimore Polytechnic Institute. 

Michael’s experience includes cardiovascular, nuclear medicine, general surgery and orthopaedic medical devices, and IVDs for clinical chemistry, microbiology, immunology and haematology devices in a variety of formats (IHC, ELISA, IFA, lateral flow, genotyping).

My areas of expertise

Medical devices and IVD.

INTERNATIONAL HEALTH ECONOMICS ASSESSMENT

US domestic regulatory strategies and submissions for medical devices and IVDs (Q-Sub, IDE, 510(k), PMA).

International regulatory strategies and submissions for medical devices and IVDs (Health Canada licensure; CE Mark in conformity with the EU MDR and IVDR). 

GO-TO-MARKET ANALYSIS

Gap-assessment of existing technical files/design dossiers against the new requirements of the EU MDR and IVDR.

Design, implementation and audit of quality management systems for medical devices (21 CFR Part 820 and ISO 13485).