Dr. Maria Donawa MD

Council Member Biography

Maria Donawa, MD, is the President and Founder of Donawa Life- science Consulting which provides regulatory and quality system services and is a full service European CRO, with offices in Italy, the UK, Switzerland and US. Dr. Donawa has over 30 years of regulatory experience including six years at the US FDA CDRH. She holds US degrees in pharmacy and medicine and post-doctoral specialization in clinical and anatomical pathology. Dr. Donawa has served as a quality system registered lead auditor, is a former member of the GHTF SG 3 (quality management system requirements), a current member of ISO TC 210 WG 1 (ISO quality system standard for medical devices), a current member of ISO TC 194, WG 4 (ISO standard on medical device clinical studies), regulatory affairs columnist for medical device technology magazine (a European medical device trade publication), a former member of the Board of Directors of the Regulatory Affairs Professionals Society, and a regular speaker at US and European conferences. (This is me - Update Profile)

Employment History

1986 - Unspecified

President, Donawa Lifescience Consulting

1983 - 1986

Assistant Director for Device Safety and Risk Mana, FOOD & DRUG ADMINISTRATION

1980 - 1983

Special Medical Consultant, FOOD & DRUG ADMINISTRATION