IEC 62366 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-62366-vs-iso-14971
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Explore individual standards
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7
What's actually different
StatusCurrent — recognized consensus standardCurrent — recognized consensus standard
Effective period2015 – present (Amd 1:2020)2019 – present
Total requirements149
Risk integrationUse-error risks via ISO 14971Defines the framework
Plan maintenanceUsability Engineering File maintained throughout device lifecycleRisk Management Plan updated through post-production phases
Document approvalUsability Evaluation Plan and Report require documented approvalRisk Management Plan and Report require formal approval before release
Most common gapUsability engineering disconnected from risk management fileRisk file created post-design; not updated after field actions
Audit focusUsability File completeness, use scenario traceability, summative coverageRisk file integrity, control hierarchy rationale, post-market feedback loop
What's shared, what's distinct
6
- • RISK CONTROL as it relates to USER INTERFACE design
- • Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS
- • Identify and describe HAZARD-RELATED USE SCENARIOS
- • Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION
- • Hazard Identification and Risk Estimation
- • Risk Control Option Analysis
10
- • Usability Engineering Process
- • Usability Engineering File
- • Use Specification
- • Identify known or foreseeable Hazards and Hazardous Situations
- • Establish User Interface Evaluation plan
- • Perform Summative Evaluation of the Usability of the User Interface
- + 4 more
7
- • Risk Management Process
- • Risk Management Plan
- • Intended Use and Reasonably Foreseeable Misuse
- • Risk Evaluation Against Acceptability Criteria
- • Residual Risk Evaluation and Benefit-Risk Analysis
- • Overall Residual Risk Evaluation and Risk Management Review
- + 1 more