I have Quality Assurance, Regulatory, Product Development,Project Management, Clinical Research, and Global Sales & Marketing experience in the medical device industry. My clients are mostly small businesses and start up companies.
My specialties include medical device PMA and 510(k) submissions, CE marking and technical file creation, and Unique Device Identification (UDI) compliance.
I also have significant Quality Assurance experience including Quality Management Systems, vendor evaluation/control, risk management, CAPA's, and postmarket surveillance.
I live in the beautiful Hudson Valley Region of New York state. In my free time I enjoy hiking, skiing, and restoring and racing my 2004 Miata Mazdaspeed.