My Volunteer Profile

Maria E. Donawa, M.D., President, Donawa Lifescience Consulting Srl, headquartered in Rome, Italy, has over 30 years’ regulatory experience including 6 years with the US 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 life science companies 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.