Maria E. Donawa, MD
President, Donawa Lifescience, Italy
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.
CEO, MD-CLINICALS SA, Switzerland
With over 30 years of experience, Ms. Giroud is founder and senior faculty board member of the World Medical Device Organization (WMDO). Ms. Giroud is regarded as a recognized clinical research and regulatory expert within the medical device industry, having shared her extensive knowledge and experience with multi-national corporations and startup companies from around the globe.
She is also currently convener for the expert group on clinical investigations; TC 194 WG4 for the ISO 14155 as well as liaison with the EU Commission – CIE (Clinical Investigation and Evaluation) task force.