Medical Device Regulation: EU MDR & FDA QMSR

Seminar Overview

This seminar is taught from the primary sources themselves — not from Notified Body marketing decks or training-vendor summaries. The EU half is built from the complete text of Regulation (EU) 2017/745 (the Medical Device Regulation, MDR), studied article-by-article and annex-by-annex, from classification Rule 1–22 through Annex II technical documentation and Annex XIV clinical evaluation. The U.S. half is built from the FDA's Quality Management System Regulation (QMSR) final rule as published in the Federal Register in 2024 — the rule that incorporates ISO 13485:2016 by reference and amends 21 CFR Part 820 effective 2026 — together with the FDA's 1997 Design Control Guidance, which remains the operative playbook for design input/output, verification, validation, and transfer.

Regulatory failure in medical devices is rarely a failure of intent; it is a failure of documentation logic. Companies lose years to a technical file whose risk management file doesn't close the loop from hazard to residual-risk acceptability, a clinical evaluation report whose literature search can't be reproduced, or a design history file where verification and validation were treated as the same activity. The course teaches the documentation systems the way the regulations actually structure them.

After three days you will be able to classify a device under MDR Rules 1–22 with correct rationale, plan a conformity assessment route (Annex IX, X, XI) matched to class I/IIa/IIb/III, assemble Annex II/III technical documentation that a notified body can review, build a CER that satisfies Annex XIV and MEDDEV-style expectations, and operate a QMSR-aligned design control process under 21 CFR 820.30 — with a coherent risk management file spanning both regimes.

Ideal Learner

• Regulatory affairs and quality managers at medical device manufacturers and their suppliers
• R&D and design engineers who own design controls, V&V, and design history files
• Quality engineers preparing for notified body audits or FDA inspections
• Clinical/research staff authoring or reviewing clinical evaluation reports
• Contract manufacturers and component suppliers entering the device supply chain

Learning Objectives

• Classify devices under EU MDR 2017/745 Rules 1–22 and document the classification rationale
• Select and plan the conformity assessment route (Annex IX/X/XI) for class I, IIa, IIb, and III devices
• Assemble Annex II/III technical documentation structured for notified-body review
• Build a clinical evaluation report under Annex XIV, including equivalence arguments and post-market clinical follow-up logic
• Operate design controls under 21 CFR 820.30 per the FDA's 1997 Design Control Guidance: inputs, outputs, verification, validation, transfer
• Align a quality system with the FDA QMSR's ISO 13485:2016 incorporation and run UDI/EUDAMED obligations for the EU side

Consulting Sessions

Seminar attendees can sign up for individual consulting sessions with the instructor. Sessions are free for registered attendees, first-come first-served — sign up when registering by calling 248-539-0473 or during the seminar.