| 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.mdspec/mappings/dcb0129-to-safety-md.mdspec/mappings/dcb0160-to-safety-md.mdspec/mappings/iso14971-dcb-to-safety-md.mdspec/mappings/duaa2025-to-safety-md.md
Steps
- Locate safety files and determine structure. Completion: you can list canonical and supporting files.
- Apply every rule in
references/review-checklist.md. Completion: each rule has pass/fail/not-applicable/unknown status.
- Group findings by Critical / High / Medium / Low. Completion: severity reflects safety/evidence impact, not style preference.
- Patch safe, mechanical issues if requested or clearly in scope. Completion: no meaning-changing edits without confidence.
- 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.
