The FDA places heavy regulatory burdens on medical device manufacturers and pharma. Dr. Teitel has broad experience with medical devices from medical, legal, and regulatory viewpoints. His experience spans Class II medical devices, including diagnostics, as well as Class III implantables. Whether developing a regulatory strategy for a start-up or early-stage company, updating an established regulatory plan, or designing clinical trials to support FDA submissions, Dr. Teitel’s experience can help. He also has experience with Health Hazard Evaluations, product recalls and assisting management with their FDA interactions, including meetings at the FDA. Having been a Chief Medical Officer in industry and a medical device company CEO, in addition to being an end user of devices as a practicing surgeon, he has a unique understanding of how regulatory issues affect a medical device company’s operations and bottom line.
An international regulatory strategy is more than just a “mini-FDA” plan. Many counties have differing regulatory pathways. Therefore, it’s important to develop a global regulatory strategy when mapping out a medical product’s regulatory plan that includes international markets.
Dr. Teitel and The Teitel Firm stand ready to assist on all regulatory and FDA matters.