Michael Wienholt

Michael Wienholt has been working in FDA regulated industry, including both medical devices and in vitro diagnostics (IVDs), for the past 25 years. The first 11 of these years were focused in research, product development, and chemistry manufacturing of IVDs. The subsequent 14 years have been focused in regulatory affairs and quality compliance for both medical devices and IVDs, including consulting for private clients as well as in service to several global CRO's as an affiliate consultant specializing in IVDs. His experience includes Class II and Class III devices for cardiovascular, nuclear medicine, general surgery and orthopedic medical devices, and IVDs for clinical chemistry, microbiology, immunology and hematology devices in a variety of formats (IHC, ELISA, IFA, lateral flow, genotyping).

Michael has a record of successful domestic and international regulatory submissions for medical devices and IVDs and I have managed both FDA inspections and Notified Body audits. He has assisted device manufacturers in achieving certification to ISO 13485:2003, including the design and implementation of the QMS from the ground up. Michael 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. He enjoys the challenge of aligning the research, regulatory, quality, clinical and marketing plans with the shared goal of delivering validated products to the marketplace that benefit both the patient and the clinician.

Experience

•       11 years experience in research, chemistry manufacturing and quality for immunodiagnostics (Epitope, Oregon Health Sciences University, Quidel).

•       14 years experience in regulatory and quality compliance for medical devices and diagnostics (Abbott Diagnostics, Guidant Endovascular, Ventana, Sequenom, Accumetrics).

•       Senior Regulatory & QA Consultant with Emergo Group, Austin TX (2010-­‐2011).

•       Affiliate Consultant with Beaufort Advisors LLC, Norfolk VA (2010-­‐2013).

•       Owner and Principal Consultant, (2006 – Present)

Regulatory Submissions

•       FDA clearance of a computed tomography device for radiology (K000908).

•       FDA clearance of a brachytherapy source for radiology (K020683).

•       FDA clearance of a rapid, lateral flow IVD for detection of Giardia (K081064).

•       FDA clearance of an electrosurgical generator for endoscopic surgery (K113265).

•       FDA clearance of a pediatric angiography catheter (K113819).

•       Multiple Class 2 medical device licenses obtained from Health Canada for devices and diagnostics.

•       Conformity assessments and technical files for CE marking to both the Medical Devices Directive (MDD) and the In Vitro Diagnostics Devices Directive (IVDD) for multiple devices and IVDs.

Publications

•       Detection of Antibodies to Helicobacter pylori Using Oral Fluid Specimens, Annals of the New York Academy of Sciences, Vol. 694, September 20, 1993.

•       Fundamentals of US Regulatory Affairs, 7th Edition, Chapter 18: In Vitro Diagnostics Submissions and Compliance, Regulatory Affairs Professionals Society, July 2011.

Certifications

•       RAC, United States Regulatory Affairs, Regulatory Affairs Certification Board, Regulatory Affairs Professional Society, November 3, 2001 (RAC I.D. # 010001424).

•       RAC, European Union Regulatory Affairs, Regulatory Affairs Certification Board, Regulatory Affairs Professional Society, November 2, 2002 (RAC I.D. # 900025526).

•       Accredited Lead Auditor, Medical Device Quality Systems, ANSI-­‐RAB National Accreditation Program, Excel Partnership, Inc., November 29, 1999 (Certificate # 9319).