MED-004

Pack: F_OVERLAY Severity: major

Design changes: controlled, reviewed, documented

Rule Card

Field	Value
Pack	F_OVERLAY — Industry Overlay and Compliance
Title	Design changes: controlled, reviewed, documented
Severity	major
Check logic	LLM-assisted
Applies to	Compliance overlay
Inputs required	manual_context
Fix template	Add required compliance evidence and overlay-specific controls.

Short Description

Design changes: controlled, reviewed, documented

When It Applies

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

Evidence Profile

Input	Category
manual_context	Manual context

References

Reference	Type	Title
REF-MED-QMS	standard	ISO 13485: Medical devices QMS requirements

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