Eduardo March, MS

Senior Regulatory Consultant

Ed has over 27 years of experience working in the medical device regulatory arena, both within FDA and the medical device industry. He has been providing advice and consultation to industry on regulatory, technical and other medical device-related matters. While at FDA, he specialized in the review, evaluation and approval of medical devices during premarket approval processes.

In addition Ed has extensive knowledge of regulatory compliance and quality systems used by FDA to regulate the medical device industry. He has performed pre-approval audits, cGMP audits of medical device manufacturers, and clinical study audits for his clients. Ed advises clients on the preparation of submissions to obtain approvals (PMA’s and IDE’s) and clearance (510(k)) to market medical devices and the development of quality assurance systems and procedures that comply with the agency’s medical device regulation (Quality System Regulation).