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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').

71

Quality

88%

Does it follow best practices?

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SecuritybySnyk

Passed

No findings from the security scan

The canonical home for this skill is mdr-745-specialist in alirezarezvani/claude-skills

SKILL.md
Quality
Evals
Security

Quality

Content

77%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.

The body is a well-organized, largely concise reference with strong numbered workflows and explicit validation steps. Its main weakness is progressive disclosure: the SKILL.md signals reference files and a gap-analyzer script that are not present in the bundle, weakening both navigation and actionability.

Suggestions

Add the missing bundle files referenced in the body (references/mdr-classification-guide.md, references/clinical-evidence-requirements.md, references/technical-documentation-templates.md) or remove the dangling references so navigation targets resolve.

Either include scripts/mdr_gap_analyzer.py in the bundle or replace the concrete script invocation with a documented placeholder so the actionability examples are genuinely executable.

Consider moving the larger quick-reference tables (classification matrix, conformity assessment routes, PSUR schedule) into the reference files to keep SKILL.md as a lean overview and improve conciseness.

DimensionReasoningScore

Conciseness

Largely efficient tables and numbered lists with no padding of concepts Claude already knows, though several quick-reference tables (classification matrix, PSUR schedule, conformity routes) could arguably live in the reference files rather than inline in SKILL.md. Not a 5 because some inline reference-style material could be pushed deeper; not a 3 because what remains is genuinely task-critical and tightly written.

4 / 5

Actionability

Provides concrete, specific guidance with real article citations (Art. 86, GSPR 1-3/10.1/17/23) and executable script invocations ('python scripts/mdr_gap_analyzer.py --device "Device Name" --class IIa'). Not a 5 because the referenced script (scripts/mdr_gap_analyzer.py) is not present in the bundle, so the example cannot be copy-paste run as written.

4 / 5

Workflow Clarity

Each of the five major processes is a clearly numbered 1-8 sequence with an explicit bolded validation checkpoint (e.g., '**Validation:** Classification confirmed with Notified Body', '**Validation:** Technical file reviewed for completeness'), matching the top anchor for sequenced workflows with explicit validation.

5 / 5

Progressive Disclosure

Structure is good with a dedicated Reference Documentation section pointing one level deep to references/*.md files, but the referenced bundle files (references/mdr-classification-guide.md, clinical-evidence-requirements.md, technical-documentation-templates.md) and scripts/mdr_gap_analyzer.py do not exist in the bundle, so the navigation signals point at missing targets. Not a 4 because the signaled references are not real files; not a 2 because the overall structure and signaling are sound.

3 / 5

Total

16

/

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.

The description is exemplary: it states concrete capabilities, provides natural trigger phrases with example queries, and uses clean third-person voice. It clearly answers both what the skill does and when to invoke it with minimal conflict risk.

DimensionReasoningScore

Specificity

Lists multiple concrete actions spanning 'classification, technical documentation, clinical evidence, and post-market surveillance' plus 'classifying... building or gap-checking a technical file, planning clinical evaluation or PMS/PSUR cadence, preparing for notified body review', giving comprehensive coverage of specific capabilities.

5 / 5

Completeness

Explicitly answers both 'what' (compliance specialist for classification, technical files, clinical evidence, PMS/PSUR, EUDAMED) and 'when' with an explicit 'Use when...' clause and concrete example trigger phrases.

5 / 5

Trigger Term Quality

Comprehensive natural-language triggers including example user queries ('what class is my device under MDR', 'review my PSUR schedule') and domain terms users actually say (MDR compliance, notified body, EUDAMED, PMCF, UDI, clinical evaluation).

5 / 5

Distinctiveness Conflict Risk

Occupies a clear niche (EU MDR 2017/745) with highly specific regulatory triggers and example queries, making conflict with unrelated skills unlikely.

5 / 5

Total

20

/

20

Passed

Validation

87%

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

Validation14 / 16 Passed

Validation for skill structure

CriteriaDescriptionResult

frontmatter_unknown_keys

Unknown frontmatter key(s) found; consider removing or moving to metadata

Warning

referenced_paths_exist

Referenced path issues: 6 missing

Warning

Total

14

/

16

Passed

Repository
alirezarezvani/claude-skills
Reviewed

Table of Contents

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