FREE REGULATORY TOOLKIT
QMSR Transition Checklist
Identify what your organization can evidence today—and where a structured gap assessment should begin.
This practical 28-point orientation checklist helps medical-device quality and regulatory teams review key transition considerations under 21 CFR Part 820, as amended by the FDA Quality Management System Regulation (QMSR), effective February 2, 2026.
- 28 focused review points
- References to relevant regulatory sections
- Seven key QMSR readiness areas
- Practical guidance for organizing your findings
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What You Will Assess
The checklist guides you through seven areas:
- Scope and applicability
- Quality management system documentation
- Terminology and document migration
- Control of records and FDA supplemental requirements
- Device labeling and packaging controls
- Risk-based thinking across the quality system
- Inspection readiness
Each item is designed to help you determine whether your organization can produce objective evidence today—not merely whether a process is believed to exist.
Who This Checklist Is For
- Medical-device quality and regulatory professionals
- Finished-device manufacturers preparing for QMSR
- Startups establishing or updating their quality systems
- Organizations evaluating how QMSR applies to their activities
- Teams preparing documentation for inspection readiness
How to Use It
Work through each item and mark those your organization can currently evidence. For unchecked items:
- Separate “we do this but cannot show it” from “we do not do this.”
- Prioritize findings by regulatory and inspection exposure.
- Group related findings by procedure or document.
- Assign ownership and retain a dated record of the assessment.
The checklist identifies where to look. A complete gap assessment should also document what was found, who owns each action and how the gap was closed.
Prepared by Abdon Marques Cunha
Founder and Principal Consultant, AVRA Medical Consulting LLC
Abdon Marques Cunha is a clinical and electrical engineer with more than 25 years of experience across clinical engineering, medical-device operations, technical leadership and regulatory documentation. He is an ISO 9001:2015 Lead Auditor certified by TÜV Rheinland and has specialized training in U.S. FDA medical device regulations.
AVRA Medical Consulting helps medical-device organizations strengthen QMSR readiness, quality systems, design controls, risk management, usability documentation, labeling and technical documentation.
Start Your QMSR Review
Download the checklist and identify the areas that deserve closer assessment.
This checklist is provided for general orientation only. It is not legal or regulatory advice, does not establish or demonstrate compliance and is not affiliated with or endorsed by the U.S. Food and Drug Administration. It contains no text reproduced from ISO or IEC standards. Verify all requirements against the current regulation and your licensed copies of the applicable standards.