Quality Management System Regulation (QMSR) - 21 CFR Part 820

The new text (Final Rule) published by the FDA on February 2, 2024 amending the Current Good Manufacturing Practice (CGMP) requirements documented in 21 CFR Part 820 of the Quality System Regulation (QSR), incorporates by reference the ISO 13485: 2016 standard. The new requirements, known as the Quality Management System Regulation (QMSR), come into force on 02/02/2026.

It enables participants to understand the requirements for implementing or improving a QMS in order to comply with QMSR.

• Know the scope and content of ISO 13485: 2016 and the new rules of 21 CFR Part 820 (QMSR).
• Be able to draw up an action plan for QMSR compliance.
• Be prepared for FDA inspections.

MODULE 1: Background to medical device regulation in the US.

Module objectives: Understand the regulatory context in which the FDA has published the final rule (QMSR), know the main GAPs between QSR, QMSR and ISO 13485: 2016 and present the 2 key ISO 13185: 2016 approaches (process approach and Risk-based approach).

• Regulatory context
• Principle of incorporation by reference
• QMSR, what’s inside?:
• Scope (§ 820.1)
• Definitions (§ 820.3)
• Requirements for QMS (§ 820.10)
• Control of records (§ 820.35)
• Device labeling and packaging controls (§ 820.45)
• Round table : GAP QSR vs QMSR & QMSR vs ISO 13485 : 2016
• Process and Risk-based approaches
• Round table : Process / Risk- based Approaches
• Exercises

MODULE 2 :  Quality Management System (according to ISO 13485: 2016)

Module objectives: Know and understand the requirements of ISO 13485: 2016 incorporated by reference.

• General, concepts, terms and definitions
• QMS requirements according to ISO 13485: 2016 and QMSR
• Control of documents and records requirements, including QMSR specificities
• PDCA
• Exercises

MODULE 3 :  Management responsibility

Module objectives: understand the responsibilities of top management as defined by ISO 13485: 2016.

• Management commitment
• Customer focus
• Quality policy and quality objectives
• QMS planning
• Management representative
• Internal communication
• Management Review
• Exercises

MODULE 4 : Resource management

Module objectives: understand the standard's requirements for resource management.

• Provision of resources
• Human resources
• Infrastructure
• Working environment & Contamination control
• Exercises

MODULE 5 : Product realization

Module objectives: Understand the requirements of ISO 13485: 2016 with regard to the product

realization process, the management design changes, and the importance of risk management along the entire product realization process.

• Round table
• Definitions
• Product realization planning
• Risk management process
• Méli-Mélo Risk management process
• Customer-related process
• Design and development
• Méli-Mélo Change management process
• Purchasing
• Round table_ activities
• Production and Service provisions_Focus on QMSR specifities
• Control of labeling and packaging activities
• Identificationà21 CFR Part 830 (UDI)
• Traceabilityà 21 CFR Part 821 (MD Tracking)
• Exercices : « My process »
• Control of monitoring and measurement equipment
• Exercises

MODULE 6 : Measurement and improvement

Module objectives: Understand the requirements of ISO 13485: 2016 concerning analysis and improvement, and acquire tools for managing non-conformities and corrective and preventive actions.

• General
• Monitoring and measurement including QMSR specificities
• MD reportingà 21 CFR Part 803 (Advisory Notice)
• MD CAPA & Recallà 21 CFR Part 806
• Control of non-conforming product
• Data analysis
• Case studies
• Improvement
• Exercices

Alternating theory, case studies and games.

Training support in English.

Training presentation in French or English.

• End-of-training assessment in the form of an MCQ.
• Evaluation of satisfaction at the end of training.