This Excel reference supports medical-device QMS gap analysis across documentation, management responsibility, resources, product realization, monitoring and improvement.
Download the QMS comparison assessment table (original Excel file)
Check the regulatory version before use
FDA's Quality Management System Regulation (QMSR) took effect on February 2, 2026. Current 21 CFR Part 820 incorporates ISO 13485:2016 by reference and retains additional US requirements. The attached comparison labelled “QSR” is a historical reference for preliminary gap analysis; it is not a complete checklist for current QMSR compliance.
The attachment's chapter groupings are an organizational aid. Verify each item against the official standard, applicable regulations and product scope. Review the basis for summarized requirements and differences before relying on them.
Overall compliance recommendations
- Build a common QMS framework on ISO 13485. ISO 13485:2016 is a medical-device quality management system standard focused on applicable regulatory requirements, risk management and maintaining system effectiveness. It can provide a foundation for integrating systems across markets.
- Distinguish EU legal duties from how standards are used. The MDR requires manufacturers to establish an appropriate quality management system. Use of a cited harmonized standard is voluntary and can provide a presumption of conformity for the requirements it covers. Do not describe ISO 13485 certification as a universal mandatory condition for every CE route.
- Address current QMSR requirements for the US market. In addition to incorporated ISO 13485:2016, assess FDA supplemental provisions and other applicable duties. An ISO 13485 certificate does not replace FDA regulatory compliance or inspections. Keep traceable evidence for records, complaints, nonconformities and corrective and preventive action.
- Connect gap analysis to actual improvements. Establish a shared QMS first, then add market-specific requirements. Track each gap with an owner, due date and effectiveness check to support a “one system, multiple markets” approach.
Suggested workflow
| Step | What to do | Suggested output |
|---|---|---|
| 1. Confirm scope | Identify products, sites, outsourced activities and target markets. | Applicable regulations and responsibility list |
| 2. Check current requirements | Recompare the original QSR fields with current QMSR, ISO 13485 and market requirements. | Clause sources and version history |
| 3. Review objective evidence | Examine procedures, design and production records, complaints and CAPA implementation. | Gaps, evidence locations and assessment results |
| 4. Track improvements | Assign owners, deadlines and verification methods; confirm effectiveness. | Improvement tracker and effectiveness records |
Official references
- FDA: Quality Management System Regulation (QMSR)
- FDA: QMSR frequently asked questions
- European Commission: Harmonised standards for medical devices and voluntary use
Related reading: MDR and FDA comparison assessment table.