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medical-device-mdr-auditor

Audit medical device technical files against EU MDR 2017/745 regulations.

32

Quality

27%

Does it follow best practices?

Impact

No eval scenarios have been run

SecuritybySnyk

Critical

Do not install without reviewing

Optimize this skill with Tessl

npx tessl skill review --optimize ./scientific-skills/Academic Writing/medical-device-mdr-auditor/SKILL.md
SKILL.md
Quality
Evals
Security

Quality

Content

14%

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

This skill is heavily padded with generic boilerplate sections (security checklists, lifecycle status, evaluation criteria, response templates, risk assessments) that provide no MDR-specific value and consume significant token budget. The genuinely useful content—MDR check points, compliance levels, output format, and parameter documentation—is buried within repetitive and circular generic scaffolding. The skill would benefit enormously from stripping all boilerplate and focusing exclusively on the domain-specific MDR audit workflow.

Suggestions

Remove all generic boilerplate sections (Risk Assessment, Security Checklist, Lifecycle Status, Evaluation Criteria, Response Template, Output Requirements, Input Validation) that don't contain MDR-specific information—these waste tokens on things Claude already knows.

Consolidate the three competing workflow descriptions (Example Usage run plan, Implementation Details, Workflow) into a single, concrete, MDR-specific audit workflow with explicit validation checkpoints (e.g., 'verify device class determines which checks apply before running').

Replace the hardcoded local path (/Users/z04030865/...) with a relative path, and eliminate duplicate command listings (py_compile and --help appear in multiple sections).

Move the MDR check points section to the top as the primary content since it's the most valuable domain-specific guidance, and add concrete examples of how to evaluate each checkpoint (e.g., what constitutes a valid Clinical Evaluation Plan).

DimensionReasoningScore

Conciseness

Extremely verbose and repetitive. Contains numerous boilerplate sections (Risk Assessment, Security Checklist, Lifecycle Status, Evaluation Criteria, Response Template) that add no domain-specific value. Multiple sections reference each other circularly ('See ## Prerequisites above', 'See ## Usage above'). The same commands (py_compile, --help) appear in multiple places. Generic instructions about error handling and output requirements explain things Claude already knows.

1 / 3

Actionability

The MDR check points with specific regulation references (Annex XIV Part A, Article 83) and the JSON output format example are genuinely useful and concrete. The parameter table and CLI examples provide some executable guidance. However, much of the 'workflow' is generic boilerplate rather than domain-specific instructions, and hardcoded local paths (/Users/z04030865/...) reduce portability.

2 / 3

Workflow Clarity

There are multiple competing workflow sections ('Example Usage' run plan, 'Implementation Details', 'Workflow' section) that are all generic and vague ('Confirm the user objective', 'Validate that the request matches the documented scope'). No specific validation checkpoints for the actual MDR audit process. The audit workflow itself—how to actually check compliance of documents against MDR requirements—is never clearly sequenced with verification steps.

1 / 3

Progressive Disclosure

Monolithic wall of text with 20+ sections, many of which are boilerplate. References to 'references/audit-reference.md' exist but no bundle files are provided. Circular internal references ('See ## Prerequisites above') create confusion. Content that should be in separate files (security checklist, risk assessment, evaluation criteria, response template) is inlined, while the actual domain-specific MDR guidance that should be prominent is buried among generic sections.

1 / 3

Total

5

/

12

Passed

Description

40%

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 identifies a clear and distinctive regulatory niche (EU MDR medical device auditing), which is its main strength. However, it is a single sentence that lacks a 'Use when...' clause and does not enumerate specific actions or sub-tasks, making it incomplete for skill selection among many options.

Suggestions

Add an explicit 'Use when...' clause, e.g., 'Use when the user asks about EU MDR compliance, medical device regulatory audits, technical documentation review, or CE marking requirements.'

List specific concrete actions such as 'Reviews Annex II/III documentation, checks device classification, validates clinical evaluation reports, identifies compliance gaps, and generates audit findings.'

Include common user-facing trigger terms like 'regulatory compliance', 'CE marking', 'technical documentation', 'MDR checklist', and 'conformity assessment' to improve keyword coverage.

DimensionReasoningScore

Specificity

Names the domain (medical device technical files) and one action (audit), but does not list multiple specific concrete actions like identifying gaps, checking classification, validating clinical evidence, etc.

2 / 3

Completeness

Describes what the skill does (audit technical files against EU MDR) but completely lacks a 'Use when...' clause or any explicit trigger guidance for when Claude should select this skill. Per rubric guidelines, missing 'Use when' caps completeness at 2, and the 'what' is also thin, warranting a 1.

1 / 3

Trigger Term Quality

Includes relevant keywords like 'medical device', 'technical files', 'EU MDR 2017/745', and 'audit', but misses common variations users might say such as 'regulatory compliance', 'CE marking', 'conformity assessment', 'Annex II', 'technical documentation', or 'MDR checklist'.

2 / 3

Distinctiveness Conflict Risk

The combination of 'medical device technical files' and 'EU MDR 2017/745' is a very specific regulatory niche that is unlikely to conflict with other skills.

3 / 3

Total

8

/

12

Passed

Validation

90%

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

Validation10 / 11 Passed

Validation for skill structure

CriteriaDescriptionResult

frontmatter_unknown_keys

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

Warning

Total

10

/

11

Passed

Repository
aipoch/medical-research-skills
Reviewed

Table of Contents

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