Maria E. Donawa, M.D. is President, Donawa Lifescience Consulting Srl, headquartered in Rome, Italy. Dr. Donawa has over thirty years’ regulatory experience including six years with the US Food and Drug Administration (FDA) in the area of medical device regulation. In 1986, after moving to Rome, Italy, she founded two consecutively operating companies, which have become Donawa Lifescience Consulting Srl (DLC). The DLC team of experts provides US and European quality system, regulatory and clinical services to life science companies worldwide.
Dr. Donawa assists medical device and in vitro medical device companies, including producers of drug delivery and drug/device combination products, in complying with US and European medical device regulatory and quality system requirements; conducts FDA mock audits; helps companies develop an effective clinical strategy; manages US Pre-Submission projects; develops European Clinical Evaluation Reports; and, is assisting companies in preparing for compliance with the European Medical Device Regulation and In Vitro Diagnostic Regulation.
In addition, Dr. Donawa is an active member of the international standards group responsible for the development and revision of ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical practices, harmonized in Europe as EN ISO 14155. She has also served as a UK Institute of Quality Assurance registered lead auditor and provided notified body auditing services to a German notified body for five years. For over 25 years, she was the regulatory affairs columnist for European Medical Device Technology until closure of the publication. In addition, Dr. Donawa is a former Member of the Board of Directors of the Regulatory Affairs Professionals Society and holds US degrees in pharmacy and medicine, with a post-doctoral specialty in clinical and anatomical pathology. She is also a regular speaker at US and European conferences.