safety-md-review

name	safety-md-review
description	User-invoked skill for reviewing SAFETY.md, CSMF, DCB0129, or DCB0160 documentation for safety, evidence, and terminology gaps.
disable-model-invocation	true

SAFETY.md Review

Use only when the user explicitly asks for this skill or asks to review clinical safety documentation.

Read first

Read references/review-checklist.md. Then read the following from the installed shared bundle at ../_safety-md/, or from the canonical SAFETY.md repository root if that bundle is absent:

• GLOSSARY.md
• spec/mappings/dcb0129-to-safety-md.md
• spec/mappings/dcb0160-to-safety-md.md
• spec/mappings/iso14971-dcb-to-safety-md.md
• spec/mappings/duaa2025-to-safety-md.md

Steps

1. Locate safety files and determine structure. Completion: you can list canonical and supporting files.
2. Apply every rule in references/review-checklist.md. Completion: each rule has pass/fail/not-applicable/unknown status.
3. Group findings by Critical / High / Medium / Low. Completion: severity reflects safety/evidence impact, not style preference.
4. Patch safe, mechanical issues if requested or clearly in scope. Completion: no meaning-changing edits without confidence.
5. Put questions in queries.md where facts require user/CSO input.

Completion criteria

• Findings are prioritised.
• Unsupported compliance/approval claims are flagged.
• Manufacturer/deployer role confusion is flagged.
• Missing evidence is distinguished from missing wording.
• DUAA2025-relevant omissions are assessed.

Common Gotchas

• Do not “fix” missing evidence by writing assertions.
• Do not remove legacy attribution just because it looks old; preserve provenance unless clearly stale/noisy.
• A clean-looking document can still fail if hazards lack evidence or residual-risk acceptance.