Roberto Cunha

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.