Understanding QMSR: Key Updates & Compliance Changes

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Manufacturers of medical devices intending to market their products in the United States are currently required to comply with the U.S. FDA’s 21 CFR Part 820: Quality System Regulation (QSR). Non-compliance with any applicable provision of the QSR renders a device adulterated under Section 501(h) of the Food, Drug, and Cosmetic Act, and may result in regulatory action against both the product and the responsible individuals.

On February 2, 2024, the FDA issued a final rule that replaces the QSR with a new regulation—the Quality Management System Regulation (QMSR)—which harmonises U.S. requirements with ISO 13485:2016. The QMSR will officially come into effect on February 2, 2026. Organisations already certified or aligned with ISO 13485:2016 are expected to experience minimal disruption. However, manufacturers currently operating solely under 21 CFR Part 820 and not aligned with ISO 13485 will be more significantly impacted.

This course provides a detailed overview of the QMSR structure and highlights the key updates and additional requirements beyond ISO 13485:2016. A working knowledge of ISO 13485:2016 is assumed. If further knowledge on the ISO 13485:2016 is required please see more details on ISO 13485:2016 training programme.

Introduction to the FDA Quality Management System Regulation (QMSR)
Key QMSR timelines and transition expectations
Overview of the QMSR structure and layout
Discussion of individual QMSR elements
Comparison of QMSR with ISO 13485:2016:
- What’s new under QMSR
- How QMSR requirements fit within an ISO 13485:2016-compliant system

As further updates are released by the FDA (including a revised QSIT guide and compliance communications), the course content will be refreshed accordingly to reflect current guidance.

This course is ideal for all personnel involved in the development, implementation, and maintenance of Quality Management Systems, including:

Quality Professionals
Regulatory Affairs Personnel
Engineers
Internal Auditors
QMS Implementation Leads

Participants achieve the following learning outcomes from the programme:

A clear understanding of the layout, structure, and key timelines of the QMSR
Insight into the new requirements introduced by QMSR
The ability to begin planning their organisation’s transition strategy from QSR to QMSR
A practical understanding of how QMSR fits into an ISO 13485:2016 quality framework

As more information and documents are released by FDA e.g. updated QSIT document, this course will be updated accordingly.

John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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Kevina O’Donoghue

Kevina takes great pride in the training she delivers. She unde...

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It is advised that participants have some knowledge of ISO 13485:2016 when attending this course. If further knowledge on ISO 13485 is required, please see our the ISO 13485 training programme.

In-House Courses
Course tutor will contact your organisation in advance. In-house courses can be customised to meet your organisation’s specific requirements.

Course Manual
Delegates will receive a very comprehensive course manual.

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Snapshot

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Course Code

LS047

Duration

0.5 training day

Public Price

Virtual Training: €250

Delivery Mode

This programme is delivered by Classroom, Virtual Training, or In-Company training

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