| name | regulatory-quality-systems |
| description | Review scientific software, medical-device, and lab-process work against ISO 13485-style quality systems, design controls, validation evidence, traceability, and risk management. Use when tasks mention regulatory readiness, quality management, validation, design controls, or audit trails. |
| user-invocable | true |
| license | Apache-2.0 |
Regulatory and Quality Systems
Source adaptation: BioRouter-original synthesis inspired by remaining Scientific Agent Skills and Auto-Empirical Research Skills capability clusters, rewritten under Apache-2.0. This is not copied upstream text; it is a native BioRouter routing and verification checklist.
When to Use
Use this skill when the user asks about regulatory readiness, quality management, ISO 13485, validation, design controls, or audit trails. Prefer the most specific BioRouter extension, BioSkill, or language style skill whenever a concrete platform, package, or file type appears.
Intake
Before producing output, capture:
- Research or operational question.
- Data, platform, package, or source material involved.
- Unit of analysis, model system, cohort, sample, or artifact.
- Desired deliverable: plan, code, review, table, figure, protocol, or narrative.
- Constraints: credentials, privacy, licensing, compute budget, validation standard, or external service availability.
BioRouter Routes
Use these routes when applicable:
- Platform/API work: call the relevant BRXT extension first and keep mutation/execution gated.
- Biomedical or omics data: load the relevant
bio-skills category.
- Statistical/causal claims: load
causal-identification-gates, statistical-modeling-bayes, or econometrics-toolkit.
- Evidence/citations: load
citation-temporal-integrity and claim-evidence-integrity.
- Reproducibility: load
replication-package-audit before treating the result as final.
Quality Gates
Do not present final claims until these are true:
- Provenance is explicit: source files, APIs, ids, versions, dates, or citations.
- The method matches the data-generating process and the intended claim.
- Assumptions and failure modes are listed plainly.
- Validation is tied to an actual benchmark, holdout, sensitivity check, audit trail, or source record.
- The output can be rerun, reviewed, or traced by another person.
- Anything requiring external credentials, proprietary data, wet-lab execution, or live services is marked unverified unless actually checked.
Response Shape
Return:
- Recommended route.
- Minimal next action.
- Verification checklist.
- Risks or blockers.
- Exact artifact to produce next, if any.
