QMSR / ISO 13485 vs 21 CFR Part 820 (legacy)
What's actually different between the QMS regulations medical device manufacturers must follow — clause-by-clause comparison from the Kelsey Quality crosswalk library.
kelseyqms.com/crosswalk/compare/qmsr-vs-part-820
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Explore individual standards
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46
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What's actually different
StatusCurrent (effective Feb 2, 2026)Retired (replaced by QMSR)
Effective periodFeb 2026 – present1996 – 2026
Total requirements4930+ (no requirement mapping)
Risk integrationRequired (links to ISO 14971 throughout design)Not required
Plan maintenanceRequired throughout developmentInitial plans only
Document approvalExplicit approval signatures requiredGeneral document control
Most common gapPlan-update records and design-review evidencen/a (legacy reference)
Audit focusPlan integrity, risk linkage, approval signaturesDesign control completeness
What's shared, what's distinct
46
- • Risk Control Option Analysis
- • Design and Development Planning
- • Design and Development Inputs
- • Design and Development Review
- • Risk Management
- • Management Review
- + 40 more
3
- • Feedback / Post-Market Surveillance
- • Regulatory Reporting
- • Customer Property
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- No items.