David Teicher, M.Sc., J.D., Counsel

dteicher@gardner.law
‭+1 (651) 430-7150  office
‭+1 (763) 464-1795  mobile

Dave has a thirty-five year career specializing in FDA regulatory affairs. His practice focuses on regulatory strategies, preparing domestic submissions, and creating and implementing quality systems for compliance with FDA’s QSR and international regulations and standards.

Dave started his career as an investigator biomedical engineer in the FDA’s Los Angeles and Minneapolis District Offices where he conducted approximately 300 quality assurance audits of medical device manufacturers in the United States and internationally including manufacturers of cardiac pacemakers, mechanical heart valves, angioplasty catheters, dialysis, anesthesia and respiratory care equipment, and intraocular lenses. He then worked for private industry in management roles at various medical device companies. Dave also taught for the graduate level Regulatory Affairs and Services program at St. Cloud State University as an adjunct assistant professor.

300+


FACTORY QA AUDITS AS FDA INVESTIGATOR AND COMPANY REGULATORY AFFAIRS

5


NUMBER OF VINTAGE ROAD RACE CARS OWNED AND RACED IN THE PAST 10 YEARS

In my forty years of FDA regulatory experiences I have seen the good, the bad, and the ugly in all their varieties. I’ll have a solution no matter what the issue.
– David Teicher, M.Sc., J.D.
Practice areas:
  • Quality assurance audits
  • Regulatory strategies
  • Preparing domestic submissions
  • Creating and implementing quality systems

Dave started his career as an investigator biomedical engineer in the FDA’s Los Angeles and Minneapolis District Offices where he conducted approximately 300 factory quality assurance audits of medical device manufacturers in the United States and internationally.  After leaving FDA, Dave worked in a number of private industry FDA regulatory affairs related positions for Boston Scientific and Endocardial Solutions as well as in private practice as a FDA regulatory attorney.

  • Adjunct Professor for the graduate level Regulatory Affairs and Services program at St. Cloud State University
  • Juris Doctor from the Mitchell Hamline School of Law
  • Master of Science Biomedical Engineering from the University of Southern California
  • Bachelor of Science in Biology with a minor in Chemistry from San Diego State University

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