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Name
Maria E. Donawa, M.D.
Title
President, Donawa Lifescience
Bio
Maria E. Donawa, M.D., is a medical device regulatory expert with more than thirty years of experience in clinical evaluation, clinical data requirements, and clinical evidence strategy for the European and US markets, particularly in complex and high-risk regulatory scenarios. She is President of Donawa Lifescience, based in Rome, Italy, and a former official of the US FDA Center for Devices and Radiological Health.
Dr. Donawa holds US degrees in pharmacy and medicine, with a post-doctoral specialty in clinical and anatomical pathology. She is an active stakeholder member of the European Commission Clinical Investigation and Evaluation, Performance Studies and Evaluation (CIEPSE) Working Group, contributing to the development of European guidance on clinical investigations and clinical evaluation. She is also a longstanding member of ISO TC 194 Working Group 4, which develops international standards for medical device clinical investigations and clinical evaluation.
Her work includes clinical evaluation, post-market clinical follow-up, and clinical evidence strategy for medical devices. Dr. Donawa publishes and presents regularly on complex regulatory and clinical evidence issues. She is a member of the Regulatory Affairs Professionals Society and previously served on its Board of Directors.
Dr. Donawa holds US degrees in pharmacy and medicine, with a post-doctoral specialty in clinical and anatomical pathology. She is an active stakeholder member of the European Commission Clinical Investigation and Evaluation, Performance Studies and Evaluation (CIEPSE) Working Group, contributing to the development of European guidance on clinical investigations and clinical evaluation. She is also a longstanding member of ISO TC 194 Working Group 4, which develops international standards for medical device clinical investigations and clinical evaluation.
Her work includes clinical evaluation, post-market clinical follow-up, and clinical evidence strategy for medical devices. Dr. Donawa publishes and presents regularly on complex regulatory and clinical evidence issues. She is a member of the Regulatory Affairs Professionals Society and previously served on its Board of Directors.
