IEC 62304 vs ISO 14971
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/iec-62304-vs-iso-14971
COMPARE
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11IEC 62304 REQUIREMENTS
0SHARED IN BOTH
11NEW IN IEC 62304
9RETIRED FROM ISO 14971
SIDE-BY-SIDE COMPARISON
What's actually different
DIMENSIONIEC 62304ISO 14971
OVERVIEW
StatusCurrent — recognized consensus standardCurrent — recognized consensus standard
Effective period2006 – present (Amd 1:2015)2019 – present
Total requirements119
SCOPE
Risk integrationSoftware-specific risk via ISO 14971; class drives requirement depthFull lifecycle hazard analysis with benefit-risk conclusion required
Plan maintenanceSoftware development plan updated at each phase gateRisk management plan established before analysis begins
Document approvalVerification records required per phase and safety classRisk management file with signed risk management report
OPERATIONAL
Most common gapInternal software controls used to lower safety classificationRisk management file not updated after field actions or design changes
Audit focusClassification rationale, SOUP list currency, plan update recordsRisk file completeness, overall residual risk evaluation, post-market update triggers
COVERAGE BREAKDOWN
What's shared, what's distinct
0SHARED IN BOTH
- No items.
11ONLY IN IEC 62304
- • Software Safety Classification
- • Software Development Planning
- • Software Requirements Analysis
- • Software Architectural Design
- • Software unit implementation
- • Software System Testing
- + 5 more
9ONLY IN ISO 14971
- • Risk Management Process
- • Risk Management Plan
- • Intended Use and Reasonably Foreseeable Misuse
- • Hazard Identification and Risk Estimation
- • Risk Evaluation Against Acceptability Criteria
- • Risk Control Option Analysis
- + 3 more
OTHER COMPARISONS