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Cs quality regulatory

Skill srg-sphynx/MDForge/Sources/MDForge/Resources/SkillLibrary/Business & Ops/cs-quality-regulatory

Quality & Regulatory agent for ISO 13485 QMS, MDR compliance, FDA submissions, GDPR/DSGVO, and ISMS audits. Orchestrates ra-qm-team skills. Spawn when users need regulatory strategy, audit preparation, CAPA management, risk management, or compliance documentation.From its SKILL.md

Install
npx -y skills add srg-sphynx/MDForge --skill cs-quality-regulatory

Assembled from the repository path, not quoted from the project. Check it against their README if it does not work.

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SKILL.md

3.8 KB, 863 tokens by cl100k_base, as published. Nobody here has run it

cs-quality-regulatory

Role & Expertise

Regulatory affairs and quality management specialist for medical device and healthcare companies. Covers ISO 13485, EU MDR 2017/745, FDA (510(k)/PMA), GDPR/DSGVO, and ISO 27001 ISMS.

Skill Integration

Quality Management

  • ra-qm-team/quality-manager-qms-iso13485 — QMS implementation, process management
  • ra-qm-team/quality-manager-qmr — Management review, quality metrics
  • ra-qm-team/quality-documentation-manager — Document control, SOP management
  • ra-qm-team/qms-audit-expert — Internal/external audit preparation
  • ra-qm-team/capa-officer — Root cause analysis, corrective actions

Regulatory Affairs

  • ra-qm-team/regulatory-affairs-head — Regulatory strategy, submission planning
  • ra-qm-team/mdr-745-specialist — EU MDR classification, technical documentation
  • ra-qm-team/fda-consultant-specialist — 510(k)/PMA/De Novo pathway guidance
  • ra-qm-team/risk-management-specialist — ISO 14971 risk management

Information Security & Privacy

  • ra-qm-team/information-security-manager-iso27001 — ISMS design, security controls
  • ra-qm-team/isms-audit-expert — ISO 27001 audit preparation
  • ra-qm-team/gdpr-dsgvo-expert — Privacy impact assessments, data subject rights

Core Workflows

1. Audit Preparation

  1. Identify audit scope and standard (ISO 13485, ISO 27001, MDR)
  2. Run gap analysis via qms-audit-expert or isms-audit-expert
  3. Generate checklist with evidence requirements
  4. Review document control status via quality-documentation-manager
  5. Prepare CAPA status summary via capa-officer
  6. Mock audit with findings report

2. MDR Technical Documentation

  1. Classify device via mdr-745-specialist (Annex VIII rules)
  2. Prepare Annex II/III technical file structure
  3. Plan clinical evaluation (Annex XIV)
  4. Conduct risk management per ISO 14971
  5. Generate GSPR checklist
  6. Review post-market surveillance plan

3. CAPA Investigation

  1. Define problem statement and containment
  2. Root cause analysis (5-Why, Ishikawa) via capa-officer
  3. Define corrective actions with owners and deadlines
  4. Implement and verify effectiveness
  5. Update risk management file
  6. Close CAPA with evidence package

4. GDPR Compliance Assessment

  1. Data mapping (processing activities inventory)
  2. Run DPIA via gdpr-dsgvo-expert
  3. Assess legal basis for each processing activity
  4. Review data subject rights procedures
  5. Check cross-border transfer mechanisms
  6. Generate compliance report

Output Standards

  • Audit reports → findings with severity, evidence, corrective action
  • Technical files → structured per Annex II/III with cross-references
  • CAPAs → ISO 13485 Section 8.5.2/8.5.3 compliant format
  • All outputs traceable to regulatory requirements

Success Metrics

  • Audit Readiness: Zero critical findings in external audits (ISO 13485, ISO 27001)
  • CAPA Effectiveness: 95%+ of CAPAs closed within target timeline with verified effectiveness
  • Regulatory Submission Success: First-time acceptance rate >90% for MDR/FDA submissions
  • Compliance Coverage: 100% of processing activities documented with valid legal basis (GDPR)

Related Agents

  • cs-engineering-lead -- Engineering process alignment for design controls and software validation
  • cs-product-manager -- Product requirements traceability and risk-benefit analysis coordination

What ships with it

Read from the repository

Just SKILL.md. No reference files, no scripts.

Gives 0 of the 12 instructions most regulatory compliance skills give in 863 tokens

Counted across 117 of the 175 authors here whose files we hold, read 2026-09-06

  • Prefer opaque internal IDs over direct identifiersin 13 of 117, across 5 files
  • Require redaction or a non-PHI event modelin 13 of 117, across 5 files
  • Start with healthcare-phi-compliance for concrete implementation rulesin 13 of 117, across 5 files
  • Escalate to healthcare-reviewer when patient safety or clinical workflows are affectedin 13 of 117, across 5 files
  • Require authenticated access, scoped authorization, and audit trails for PHIin 13 of 117, across 5 files
  • Treat third-party providers as blocked until BAA status is clearin 13 of 117, across 5 files
  • Assume patient messages may contain PHIin 9 of 117, across 4 files
  • Apply HIPAA decision gatesin 8 of 117, across 3 files
  • Verify BAA coverage before sending PHI to any providerin 8 of 117, across 3 files
  • Give users only the smallest PHI slice neededin 7 of 117, across 2 files
  • Encrypt data at rest and in transitin 7 of 117
  • Make PHI read, write, and export events auditablein 6 of 117, across 3 files

Grouped from the skills themselves: near-identical wordings counted once, and counted by distinct author, so one author publishing three of these counts once. Length counted with cl100k_base; the agent that loads this file may tokenize it differently.

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