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Richard A. Vincins

Consultant / Advisor

Richard A. Vincins is part of the Emergo Group as senior consultant responsible for quality assurance and regulatory affairs activities. In this role, he is responsible for the implementation of quality systems, conducting internal audits, and providing regulatory expertise in national and international regulations. He brings 19 years of experience in the medical industry, including worldwide regulatory compliance efforts for IVD, medical device, and pharmaceutical companies. His work experience at companies such as Medtronic and bioMerieux include establishing quality systems to ISO standards and CE marking of multiple product lines. Vincins is an ASQ-certified quality auditor and holds a regulatory affairs certification for U.S. regulations and European Union regulations through the Regulatory Affairs Professional Society.

Fri, 07/17/2009 - 16:44
ISO 13485: Creating a Globally Harmonized Quality SystemAn overview of the standard's requirements and use around the world.
Fri, 07/17/2009 - 16:44
Through the 1990s, the application of a quality system relied primarily upon the Food and Drug Administrations’ (FDA) good manufacturing practice requirements or the FDA 21 CFR Part 820 Quality System Regulation. At that time, the international…
      

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