mdr-745-specialist

EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Annex VIII classification rules, Annex II/III technical files, Annex XIV clinical evaluation, Art. 86 PSUR schedules, and EUDAMED integration. Use when classifying a medical device under MDR, building or gap-checking a technical file, planning clinical evaluation or PMS/PSUR cadence, or preparing for notified body review (e.g., 'what class is my device under MDR', 'review my PSUR schedule').

Quality

89%

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The risk profile of this skill

Quality

Content

78%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

Well-structured regulatory skill body with concrete tables, executable tool invocations, and consistently validated multi-step workflows. References are properly externalized to real bundle files with clear navigation; main improvement room is tightening minor verbosity and making validation feedback loops explicit.

Suggestions

Spell out the validate->fix->retry feedback loop in each workflow (e.g., 'if the gap analysis flags critical gaps, remediate and re-run') to elevate workflow_clarity from 4 to 5.

Trim the table-of-contents and section-intro sentences that restate the obvious, and remove regulatory background Claude already knows, to improve conciseness.

Add one fully executable worked example (e.g., actual mdr_gap_analyzer.py invocation with sample output) to push actionability toward 5.

Dimension	Reasoning	Score
Conciseness	Dense, table-driven content that respects token budget and assumes competence, but includes minor padding (table-of-contents, repeated section intros, and regulatory context Claude partially knows).	4 / 5
Actionability	Provides concrete executable commands (verified 'python scripts/mdr_gap_analyzer.py --device ... --output json'), classification matrices, and GSPR checklists; minor gaps remain as most regulatory steps are checklist-style rather than fully code-driven.	4 / 5
Workflow Clarity	Every major section has a numbered 8-step workflow ending in an explicit 'Validation:' checkpoint, matching anchor 4; full validate->fix->retry feedback loops are only implicit rather than spelled out, keeping it below 5.	4 / 5
Progressive Disclosure	Clear overview with TOC, well-signaled one-level-deep references to verified real files (references/mdr-classification-guide.md, clinical-evidence-requirements.md, technical-documentation-templates.md) plus a scripts/ tool with usage; content appropriately split and easy to navigate.	5 / 5
	Total	17 / 20 Passed

Description

100%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

A strong, specific description that names concrete regulatory capabilities and provides explicit 'Use when' trigger guidance with realistic example queries. Third-person voice is maintained throughout with no vague fluff.

Dimension	Reasoning	Score
Specificity	Lists multiple concrete capability domains ('classification, technical documentation, clinical evidence, and post-market surveillance') with specific regulatory annex coverage (Annex VIII, II/III, XIV, Art. 86) and concrete actions ('classifying', 'building or gap-checking a technical file', 'planning clinical evaluation or PMS/PSUR cadence').	5 / 5
Completeness	Explicitly answers both 'what' ('EU MDR 2017/745 compliance specialist for...') and 'when' ('Use when classifying a medical device under MDR, building or gap-checking a technical file...') with concrete trigger phrases.	5 / 5
Trigger Term Quality	Includes natural trigger terms users would say ('MDR compliance', 'medical device classification', 'notified body') plus concrete example queries ('what class is my device under MDR', 'review my PSUR schedule').	5 / 5
Distinctiveness Conflict Risk	Clear niche scoped to EU MDR 2017/745 with distinct triggers (EUDAMED, PSUR, Annex VIII, notified body); minimal conflict risk with other skills.	5 / 5
	Total	20 / 20 Passed

Validation

93%

Warnings & errors only

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation — 15 / 16 Passed

Validation for skill structure

Criteria	Description	Result
frontmatter_unknown_keys	Unknown frontmatter key(s) found; consider removing or moving to metadata	Warning

	Total	15 / 16 Passed

Repository: alirezarezvani/claude-skills
Path: ra-qm-team/skills/mdr-745-specialist/SKILL.md
Commit: 19392f7

Reviewed: ~1 hour ago

Table of Contents

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