Michael Wienholt

Michael Wienholt

Regulatory affairs and quality systems compliance solutions for the medical device industry
http://www.fda-consulting.com/about-us/
Communication

In person: San Diego, CA

Skype

1-866-511-1898 x1813

Availability

Business hours (PT). By appointment.

Areas of expertise

Regulatory, Quality, FDA

Professional summary

I have been working in FDA regulated industry, including both medical devices and in vitro diagnostics (IVDs), for more than 25 years. The first 11 of years of my career 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. My 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).

I have 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. I have assisted device manufacturers in achieving certification to ISO 13485:2003, including the design and implementation of the QMS from the ground up. I hold certification (RAC) in both United States and European Union regulatory affairs from the Regulatory Affairs Professional Society (RAPS) and I am accredited by ANSI-RAB as a lead auditor for medical device quality systems. I enjoy the challenge of aligning the research, regulatory, quality, clinical and marketing plans with the shared goal of delivering to the marketplace validated products that benefit both the patient and the clinician.

Engagement overview

US domestic regulatory strategy and submissions (IDE, 510(k), PMA); CE mark technical file/design dossier to essential requirements of the MDD and IVDD directives; quality management system implementation and audit to 21 CFR Part 820 and Iso 13485:2003.

Clients

• ACON Laboratories, San Diego, CA
• Biocare Medical, LLC, Concord, CA
• Center for Surgical Invention and Innovation, Ontario, Canada
• Cytocell, Ltd., Cambridge, United Kingdom
• Diagnostics Consulting Network, Carlsbad, CA
• EDP Biotech, Knoxville, TN
• Edwards Lifesciences, Irvine, CA
• Genii, Inc., St. Paul, MN
• Glycomark, Inc., New York, NY
• Gold Standard Diagnostics, Davis, CA
• Hema Diagnostic Systems, Miami, FL
• Hycor Biomedical, Inc., Garden Grove, CA
• HydraDx, Inc., Altadena, CA
• IVD Research, Inc., Carlsbad, CA
• Kestrel Biosciences, LLC, Carlsbad, CA
• KFx Medical, Inc., Carlsbad, CA
• NexusDx, San Diego, CA
• OHMX Corp., Evanston, IL
• PediaCath, Cleveland, OH
• Prometheus Laboratories, Inc., San Diego, CA
• Rockeby Biomed, Ltd., Singapore
• Salutaris Medical, Inc., Tucson, AZ
• Sekisui Diagnostics, San Diego, CA
• Sequenom, Inc., San Diego, CA
• Université Paris Diderot, Paris, France