VP, QUALITY AND REGULATORY
DONAWA LIFESCIENCE CONSULTING, ITALY
Based in the United Kingdom (UK), 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. He has worked at Donawa Lifescience Consulting since 2007, assisting clients with gaining market access for their devices in the US and Europe, through the 510(k) and CE marking procedures, together with helping clients comply with applicable quality system requirements.
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 is a Chartered Engineer, holding a degree in Mechanical Engineering, who worked in military research, automotive R&D, and technical consulting with Cambridge Consultants Ltd before entering the medical device industry with KeyMed Ltd in 1978. Mr. Gray held numerous management positions at KeyMed which, since 1990, 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, technical services, R&D, technical marketing, technical publications, and intellectual property.
Mr Gray was involved extensively in standardization work for endoscopic equipment between the late 1980’s and mid 2000’s, acting as Secretary to both IEC 62D WG4/MT16 and ISO TC 172/SC 5/WG 6. In addition, he was a member of the Editorial Advisory Board of the European Medical Device Technology magazine since its inception in 1992 until it ceased publication in 2015, regularly contributing to its conference program. Mr. Gray has also spoken on device regulatory subjects at many seminars and conferences in Europe and the US, both before and after joining Donawa.