Bringing a medical device to market in the United States requires navigating a sophisticated regulatory framework. The Federal Food, Drug, and Cosmetic Act, 21 CFR Subchapter H, the FDA premarket pathways (510(k), De Novo, PMA, HDE, IDE), the international consensus standards (ISO 13485, ISO 14971, ISO 10993 family, IEC 60601 family, IEC 62304), and the post-market vigilance and recall frameworks together form the operating environment of every device manufacturer, contract manufacturing organization, and regulatory consultancy. For engineers, scientists, quality professionals, and career-changers entering medical-device regulatory affairs, the first task is to develop the vocabulary, the framework, and the orientation that the field expects.

This 16-hour Professional Certificate Course is the entry point of the Aleph Medical Device Regulation course track. It introduces the FDA Center for Devices and Radiological Health (CDRH) and the FDA framework under 21 CFR Subchapter H; device classification (Class I, II, III) and product codes; the principal premarket pathways at orientation depth (510(k), De Novo, PMA, HDE, IDE); the principal consensus standards — ISO 13485:2016 (Quality Management Systems for medical devices), ISO 14971:2019 (Risk Management), the ISO 10993 family (biocompatibility), and the IEC 60601 family (medical-electrical equipment); and orientation to the post-market vigilance and recall frameworks (MAUDE, MOD, 21 CFR Parts 7, 803, 806, 810).

The course prepares participants for the Advanced level (`BME-612-A`), where the same content is exercised at applied depth — premarket submission checklists, IDE clinical-investigation planning, applied MAUDE/MDR post-market analysis, recall classification, and applied work under the FDA AI/ML guidance (January 2025) for AI-enabled devices. Together the Introductory and Advanced levels form a 48-hour course track.

The Introductory course establishes the regulatory vocabulary and framework the medical-device industry expects of someone entering regulatory affairs, quality, or product-development leadership. Employers in this space include medical-device manufacturers across all categories (cardiovascular, orthopedic, in vitro diagnostic, neurological, ophthalmic, dental, surgical), contract manufacturers, regulatory-affairs consultancies, and startup medical-device companies. The Introductory level is the right starting point for professionals whose work touches medical-device regulation but who do not yet have a structured command of the framework.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.