Transition to QMSR - Quality Management System Regulation

How to master the shift to QMSR now the deadline has passed?

The deadline is here. As the FDA retires the old Quality System Regulation (QSR), the new Quality Management System Regulation  - QMSR (21 CFR Part 820)  - takes center stage. This training is your essential roadmap to navigating.

Don't be mislead: this isn’t a light transition. 
While familiar concepts like CAPA (Corrective and Preventive Action) and design controls remain, their interpretation and auditing structure have fundamentally shifted. Join us to bridge the gaps identified in early assessments, update your technical knowledge, and refine your skills as a QMSR-ready internal auditor. Ensure your Quality Management System remains compliant and inspection-ready.

“If you treat QMSR as a simple update of QSR, you’re treating marathon preparation like a warm-up exercise”

QMSR has replaced the former QSR with a framework aligned to ISO 13485:2016, while retaining FDA-specific requirements. Many organizations underestimated the impact. Core elements such as CAPA, design controls, and management responsibility remain, but are interpreted, structured, and audited differently. This training helps you close gaps, reduce compliance risk, and respond confidently to FDA inspections under QMSR.

 Why participating?

• Updating your regulatory knowledge on 21 CFR Part 820 QMSR
• Navigating the alignment with ISO 13485:2016 while mastering critical FDA-specific "add-ons”
• Identify potential risks and address gaps in the Quality Management System
• Supporting an internal auditor to function effectively under Quality Management System Regulation (QMSR).

The session includes case studies, practical examples, and live polling to translate QMSR requirements into day-to-day practice.

 What you will learn

• History background, context and alignment with ISO 13485 
• Scope and impact of Quality Management System Regulation  (QMSR)
•  Changes introduced by QMSR, comparison QSR vs QMSR Structure
•  What new in definitions, documentation
• QMR elements retained in QMSR, what stays the same?
• Mapping 21 CFR Part 820 to ISO 13485:2016
• Supplier control/purchasing process, risk-based approach, complaint handling and reporting, documentation, audits
• Under-emphasized clauses (ISO 13485): change management, validation, audits and training
• What to expect from FDA inspections under QMSR

Who will benefit from this training

• Quality Systems Manager, Quality Assurance Manager, Quality Engineer
• Supply Chain Manager, Supply Chain Engineer
• Quality Risk Compliance Experts
• Research and development / Engineering
• Document Control Specialist, System Engineer
• Complaint handling Specialist, Vigilance and PMS lead
• Manufacturing and Operations
• Regulatory Affairs Officer, QA/RA Specialist, Regulatory Compliance Officers
• Executive Management
• Internal/Supplier auditors

How to follow this transition to QMSR?

To be fully trained on QMSR, follow this QMSR workshop, participation if evidence of training ISO 13485:2016 is provided. Or, follow this QMSR workshop combined with the ISO 13485:2016 training.

Strengthen your FDA readiness beyond QMSR
QMSR is essential, but FDA expectations go beyond inspections. Combine this QMSR Transition Workshop with our 510(k) program to align your QMS with both FDA inspections and premarket submission requirements.

 Close the gaps, reduce compliance risk, and respond confidently to future FDA inspections under QMSR .

Register today and align your Quality Management System with QMSR!

Frequently Asked Questions (FAQ)

Is QMSR mandatory for all medical device manufacturers?

 Yes. QMSR (21 CFR Part 820) is mandatory for all manufacturers whose devices fall under FDA jurisdiction. Since the transition deadline has passed, FDA inspections are now conducted fully under QMSR (not under the former QSR).

Is QMSR the same as ISO 13485:2016?

No. QMSR is aligned with ISO 13485:2016, but it is not identical.
FDA-specific requirements - such as regulatory expectations around complaints, reporting, and enforcement - remain fully applicable. Organizations must comply with both ISO 13485 and FDA-specific QMSR ‘add-ons’.

Do we still need this training if we are ISO 13485 certified?

Yes. ISO 13485 certification alone does not guarantee QMSR compliance.
This workshop focuses specifically on:

• closing the gap between QSR and QMSR
• how inspections differ under QMSR
• identifying major risks and gaps in your quality system

Is this training sufficient to be fully trained on QMSR?

To be fully trained on QMSR, participants must:

• either already have documented ISO 13485:2016 training,
• or combine this workshop with the ISO 13485:2016 training.

This workshop focuses on QMSR-specific interpretation, gaps, and inspection readiness, not on teaching ISO 13485 from scratch.