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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 Read more
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.
• 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
The client - a manufacturer of in vitro diagnostic medical devices - contacted me in a state of frustration after having received a "Not Substantially Equivalent (NSE)" letter from FDA for a 510(k) submission for the company's test for Giardia. The client was eager to market the test and realize revenue growth for the business... Read more
The client performs contract design, development and manufacturing of immunoassays for manufacturers of in vitro diagnostic medical devices. In order to satisfy existing customer requests, attract more clients and grow the business, the client decided to pursue certification to the international standard for quality systems for medical devices (ISO 13485:2003). This is an expensive, lengthy and co... Read more
