Seasoned engineer with over 19 years medical device experience in quality and regulatory affairs from initial phases of product development to commercial manufacturing and post market activities.
Successful US – 510k and PMA, European Dossier/Technical File, Canadian and ROW device regulatory submissions.
Voting member for the Canadian Standards Association Medical Devices Technical Committee.
Specialties: Medical device regulatory affairs, quality assurance, risk management and usability engineering.
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