MED-003

Pack: F_OVERLAY Severity: critical

Risk management process (ISO 14971): hazards → risk controls → residual risk monitoring

Rule Card

Field	Value
Pack	F_OVERLAY — Industry Overlay and Compliance
Title	Risk management process (ISO 14971): hazards → risk controls → residual risk monitoring
Severity	critical
Check logic	LLM-assisted
Applies to	Compliance overlay
Inputs required	risk_file
Fix template	Add required compliance evidence and overlay-specific controls.

Short Description

Risk management process (ISO 14971): hazards → risk controls → residual risk monitoring

When It Applies

This rule runs only when an overlay activates F_OVERLAY. It targets Compliance overlay.

Evidence Profile

Input	Category
risk_file	Compliance / Metadata

References

Reference	Type	Title
REF-MED-RISK	standard	ISO 14971: Medical device risk management

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