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REF-MED-QMS

Field Value
Title ISO 13485: Medical devices QMS requirements
Type standard
URL https://www.iso.org/standard/59752.html
Notes Quality-system requirements for medical device lifecycle control.
Linked rules 3

Rules Using This Reference

Rule Pack Severity Title
MED-002 F_OVERLAY major QMS (ISO 13485) design/production controls: traceability + validated processes expectation
MED-004 F_OVERLAY major Design changes: controlled, reviewed, documented
SPEC-021 A_DRAWING major Revision + change note present for released drawings

Sources

  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\manifest.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\rule_library.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\references.json
  • D:\02_Code\36_RapidDraft_DFMBenchmark_ExpertMode\server\dfm\process_classifier.json
  • 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