Maria E. Donawa, MD is President, Donawa Lifescience, headquartered in Rome, Italy, with over 30 years’ regulatory experience, including six years with the US FDA, in the area of medical device regulation. Donawa Lifescience provides US and European quality system, regulatory and clinical services to life science companies worldwide.

Dr Donawa is an active member of the ISO study group responsible for the development and revision of ISO 14155, the international standard for medical device clinical investigations.

She is also a stakeholder observer to the Clinical Investigation and Evaluation (CIE) Working Group. The CIE assists the Medical Device Coordination Group (MDCG) on issues relating to clinical investigation and evaluation of medical devices in accordance with the MDR.

Dr Donawa has US degrees in pharmacy and medicine, with post-doctoral specialization in clinical and anatomical pathology.