Michael Wienholt

Michael Wienholt

Principal IVD 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 IVDs. The subsequent 21 years have been focused in regulatory affairs and quality management systems for both medical devices and IVDs. Michael’s regulatory experience includes IVDs for clinical chemistry, microbiology, immunology and hematology devices in a variety of formats (IHC, ELISA, IFA, lateral flow, genotyping, NGS).

Michael’s recent experience has been focused on implementing 21 CFR Part 820 (the FDA quality system regulation) in CLIA-licensed laboratories, which have progressed to achieving certification to ISO 13485.

Michael’s previous employment includes roles of increasing responsibility in regulatory affairs and quality at Quidel Corp., Abbott Diagnostics, Guidant Endovascular, Ventana Medical Systems, Sequenom, Accumetrics, IQVIA, and ICON. Most recently, Michael served Inivata, Inc. as Director of Regulatory Affairs for Companion Diagnostics where he was the regulatory team lead for FDA Breakthrough Device Designation granted to a ctDNA liquid biopsy assay for non-small cell lung cancer (NSCLC).

Michael earned a Bachelor of Science degree from North Carolina State University. He holds certification (RAC) in both United States and European Union regulatory affairs from the Regulatory Affairs Professional Society (RAPS) and is accredited by ANSI-­‐RAB as a lead auditor for medical device quality systems.

Competencies

  • FDA premarket submissions: QSub, IDE, 510(k), PMA.
  • CE Mark technical files (MDD, IVDD).
  • Gap assessments for transition to European regulations (MDR, IVDR).
  • Quality management system design, implementation, certification and audit (ISO 13485, FDA QSR).

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