Building on the FDA framework of the Introductory level, this Advanced course develops the European jurisdiction and the quality, post-market and emerging frameworks that complete a global regulatory strategy.

This 32-hour Professional Certificate Course covers EU MDR (Regulation (EU) 2017/745) conformity assessment with Technical Documentation Annex II/III and notified bodies; QMS compliance under §820 / QMSR (effective February 2, 2026, incorporating ISO 13485:2016 by reference); post-market surveillance under §820.198 and Part 803 and PMS + PSUR under MDR; and the emerging frameworks, the AI/ML PCCP final guidance (December 2024), the FDA cybersecurity guidance (September 2023) and the Safety and Performance Based Pathway.

By the end, participants can build a comparative FDA/EU MDR brief, outline a regulatory submission and anticipate the impact of the emerging frameworks on a regulatory strategy.

The Advanced course connects U.S. and EU device regulation with QMSR, post-market surveillance and the emerging AI/ML and cybersecurity frameworks, preparing participants for global regulatory-affairs roles.

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