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REF-MED-RISK

Field Value
Title ISO 14971: Medical device risk management
Type standard
URL https://www.iso.org/standard/72704.html
Notes Risk analysis, controls, and residual-risk evaluation process.
Linked rules 2

Rules Using This Reference

Rule Pack Severity Title
MED-003 F_OVERLAY critical Risk management process (ISO 14971): hazards → risk controls → residual risk monitoring
MED-005 F_OVERLAY major Cleanability/bioburden-related design constraints treated as DFM risks when relevant

Sources

  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\manifest.json
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  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\references.json
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  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\overlays.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\roles.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\report_templates.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\ui_bindings.json