ROGER GRAY, BSc, CEng, MIMechE, VP QUALITY AND REGULATORY, DONAWA LIFESCIENCE CONSULTING, Rome, Italy
Based in the United Kingdom, Roger Gray has worked for over 35 years in the medical device industry, specializing in European and United States regulatory and quality management requirements, in particular for electro-medical, minimally invasive and associated devices.
In the early nineties, as Chairman of the Association of British Healthcare Industries (ABHI) Technical Committee and a member of the COCIR Technical Committee, Mr. Gray was closely involved with the development of the Medical Devices Directive during its formative stages, helping to present the views of UK industry to both the UK Competent Authority and European Commission. More recently, from 1998 to 2005, he was a member of the EUCOMED regulatory affairs focus group.
Mr. Gray holds a degree in Mechanical Engineering and worked in military research, automotive R&D, and technical consulting with Cambridge Consultants Ltd, a member of the Arthur D Little Group, before entering the medical device industry in 1998 with KeyMed Ltd, which for the last 25 years has been part of Olympus Corporation, the global market leader for endoscopic equipment.
At KeyMed, he was responsible for Regulatory Affairs and Quality Assurance during his 29 years with the company, but also managed a variety of other departments, including manufacturing, repair, R&D, technical marketing, technical publications, and intellectual property.
Mr Gray joined Donawa Lifescience Consulting in 2007, and he now assists medical device companies overcome the regulatory hurdles necessary to allow market clearance of their devices in the US and European markets.