Richard Vincins - Senior Consultant, Quality Assurance & Regulatory

Richard brings a wealth of FDA and European regulatory expertise to Emergo, experience gained from 17 years of working in quality assurance and regulatory affairs with a variety of medical device companies including Medtronic, Bard, and HemaCare. Richard is well-versed in the requirements of the Medical Device Directive (MDD), In Vitro Diagnostics Directive (IVDD) and other directives for CE Marking in the European community.

In addition to his vast knowledge of quality systems regulations, Richard also has experience with clinical trial management, site qualification, monitoring and regulatory file completion. He has completed numerous CE Technical Files for IVD devices and is a certified Lead Auditor. Risk Management is also an area of expertise.