Bringing a medical device to market in the United States demands command of a sophisticated regulatory framework: 21 CFR Subchapter H, the FDA-recognized ISO/IEC consensus standards, the discipline of a 510(k) or PMA submission with its substantial-equivalence or clinical-evidence analysis, and — increasingly — FDA guidance specific to AI-enabled devices.

This instructor-led online course builds the regulatory, quality and clinical-evidence skills needed to take a medical device to market and manage it across its life cycle. It covers FDA premarket pathways in depth (510(k), De Novo, PMA, HDE, IDE) with substantial-equivalence and clinical-data analysis; international consensus standards (ISO 13485, ISO 14971, ISO 10993, the IEC 60601 family, IEC 62304); post-market surveillance (Medical Device Reporting under 21 CFR Part 803; the MAUDE database); the recall framework (21 CFR Parts 7, 806, 810); and current FDA guidance for AI-enabled devices, including Predetermined Change Control Plans, model-card transparency, data-drift monitoring and cybersecurity.