The Advanced level of the Aleph Medical Device Regulation course track is for professionals who already know the FDA framework at orientation depth and need to develop the applied skills the medical-device industry expects: building 510(k) Premarket Notification and PMA submission checklists with substantial-equivalence or evidence-of-effectiveness reasoning; planning ISO 10993 biocompatibility evaluations; classifying IEC 60601 applied parts (Type B, BF, CF); designing a clinical investigation under IDE; conducting Medical Device Reporting analysis using the FDA MAUDE and Manufacturer Online Database (MOD); classifying recalls under 21 CFR Parts 7, 806, and 810; and applying the FDA AI/ML guidance (January 2025) — including Predetermined Change Control Plan, model card transparency, data-drift monitoring, rollback, and cybersecurity — to AI-enabled medical devices.

This 32-hour Professional Certificate Course builds directly on the 16-hour Introductory level (`BME-612-I`). It does not repeat the framework orientation material. Where the Introductory level covers 510(k) and PMA at the level of definitions, the Advanced level constructs an applied 510(k) and PMA submission checklist for a chosen device with predicate selection, substantial-equivalence rationale, and the four FDA scenarios of clinical data. Where the Introductory level introduces ISO 10993 and IEC 60601, the Advanced level designs a biocompatibility evaluation plan under ISO 10993-1 and classifies IEC 60601 applied parts for a real device topology. The course culminates in a cross-functional course exercise that integrates clinical context, device technology, and regulatory pathway analysis around a chosen therapeutic area.

Graduates of the Advanced course are positioned for senior applied work in regulatory-affairs and quality roles at medical-device manufacturers across all categories, at regulatory consultancies serving device companies, at contract-research organizations supporting clinical investigations, and at AI-medical-device companies requiring applied work under the FDA AI/ML guidance. The cross-functional capstone exercise is a portfolio-grade artifact that demonstrates working command of submission, post-market, recall, and AI-device regulatory work.

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