Description: O’CONNELL REGULATORY CONSULTANTS-20 years experience in medical device regulatory and clinical affairs. FDA approvals include 510(k)’s, IDEs, and PMAs.
consultant (7641) medical device (499) fda (365) regulatory affairs (144) fda approval (13) clinical affairs (4) fda clearance (2) clinical study management (2) combination drug/device (1) fda approval for medical devices (1)