Conciseness

Efficient and well-sectioned with no explanations of concepts Claude already knows, but the 'Role & Expertise' section partially restates the frontmatter description and 'Success Metrics' are aspirational KPIs ('Zero critical findings', '95%+ of CAPAs closed') rather than execution guidance. Not 5 because those sections could be trimmed; not 3 because there is no real padding or over-explanation.

Actionability

Concrete delegation guidance throughout — each workflow step names the responsible sub-skill ('Run gap analysis via qms-audit-expert', 'Classify device via mdr-745-specialist') and cites precise regulatory anchors (Annex VIII, Annex II/III, Annex XIV, ISO 14971, Sections 8.5.2/8.5.3). Not 5 because there are no example report structures, templates, or sample outputs covering common cases; not 3 because the guidance is specific and executable, not vague direction.

Workflow Clarity

Four workflows each presented as a clear numbered sequence with a named owner per step, and some checkpoints present ('Implement and verify effectiveness', 'Mock audit with findings report'). Not 5 because explicit validate-and-retry checkpoints and error-recovery feedback loops are absent; not 3 because sequences are coherent and checkpoints are partially present rather than wholly missing — and these are documentation workflows, so the destructive/batch cap does not apply.

Progressive Disclosure

No bundle files exist, and the body correctly serves as an index: a one-line role for each sub-skill, one-level-deep references clearly signaled in the 'Skill Integration' section, with bulk detail appropriately deferred to the sub-skills themselves. Navigation is easy and no content that belongs elsewhere is inlined.

Specificity

Lists several concrete actions ('Orchestrates ra-qm-team skills', 'regulatory strategy, audit preparation, CAPA management, risk management, or compliance documentation') alongside named standards, with minor coverage gaps. Not 5 because the 'what' leans on role/domain framing ('Quality & Regulatory agent for...') rather than a comprehensive list of concrete actions; not 3 because multiple specific actions are named, not just one or two.

Completeness

Explicitly answers both: what ('Quality & Regulatory agent for ISO 13485 QMS, MDR compliance, FDA submissions... Orchestrates ra-qm-team skills') and when ('Spawn when users need regulatory strategy, audit preparation, CAPA management, risk management, or compliance documentation'). Not 4 because the when-clause is already explicit and specific with concrete trigger phrases, not something that 'could be more explicit'.

Trigger Term Quality

Good keyword coverage with natural task phrases ('audit preparation', 'CAPA management', 'risk management', 'compliance documentation') plus standard names and the GDPR/DSGVO synonym pair. Not 5 because common variations users would say — '510(k)', 'CE marking', 'technical file', 'post-market surveillance', 'ISO 14971' — are missing; not 3 because coverage goes well beyond a couple of generic keywords.

Distinctiveness Conflict Risk

Clear medical-device QMS/regulatory niche with highly distinct triggers (ISO 13485, EU MDR, CAPA), but generic tail terms like 'risk management' and 'compliance documentation' create minor overlap risk with adjacent risk/compliance skills. Not 5 because of that residual overlap risk; not 3 because the standard names dominate and the niche is unmistakable.