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BC mdr-745-specialist

EU MDR 2017/745 regulation specialist and consultant for medical device requirement management. Provides comprehensive MDR compliance expertise, gap analysis, technical documentation guidance, clinical evidence requirements, and post-market surveillance implementation. Use for MDR compliance assessment, classification decisions, technical file preparation, and regulatory requirement interpretation.

davila7/claude-code-templates Agent Skills author: davila7 MIT 4 files · 1 script body ≈ 2 047 tokens Open the sourcegithub.com↗ analyzed 6 d ago

EU MDR 2017/745 regulation specialist and consultant for medical device requirement management.

As a process C 51/100 · Has gaps — weak spots: result and completion, when it triggers, inputs and preconditions

AnalyzerSecurityWriting and documentstype and topics are labelled automatically from the skill text
Runs in: Claude / Claude Code ChatGPT / Codex Gemini CLI Cursor GitHub Copilot / VS Code Qwen Code Kimi Code CLI Z.ai (GLM) DeepSeek (Deep Code) Mistral Vibe LangChain (deepagents) OpenClaw Goose OpenCode
JSON
Technical rating
B
91/100
safety, quality, tests
Safety 60%
100
Quality 40%
77
Run on models
none yet
Process rating
C
51/100
Has gaps
Result and completion w 14
0
Inputs and preconditions w 11
0
Failures and branches w 10
0
the three weakest of ten parameters · all ten

The same skill appears in 1 more place: RA-Skills

How to improve

    For the model run — optional
    • Your own cases (evals/evals.json, 4–6 real requests with expected answers): the full check would then run those instead of a model-drafted suite.
    • A spec.yaml with trigger phrases and assertions — a behaviour contract for CI; `skilltest init` writes a template.

    Guard findings · 0

    ✓ No critical or high findings

    Files scanned: 4. Evidence is masked. Grey chips explain why severity was lowered.

    Against the Agent Skills spec

    • note edit-residue the text marks something as outdated (lines 109): check that old rules are not kept next to new ones — the full check reads the text for contradictions

    Process rating: all ten parameters 51/100

    • 0Result and completion. Does not say what the result is
    • 0Inputs and preconditions. Does not say what the process needs to start
    • 0Failures and branches. Linear process with no failure handling
    • 0Progress reporting. Says nothing while it works
    • 20When it triggers. No condition that starts the skill
    • 30Running it twice. 1 mutating operations with no state check
    • 100Tools and files. No external tools needed
    • 100Steps. 91 steps
    • 100Consistency. Name and required fields are in place
    • 100Execution cost. Instruction body is 2047 tokens

    Everything here is measured from the skill text rather than judged by a model, so the numbers are checkable. A parameter weighs more when it is a more common reason for the process to stall.

    Quality signals

    • +5Description has no quoted example phrases that should trigger the skill
    • +4Description does not say when NOT to use the skill (false activations)
    • +3Output format is not stated: the model decides each time
    • -41 reference files, but SKILL.md never points to them: the model will not open them
    • -31 of 1 scripts are never mentioned in SKILL.md
    • +1No license
    • +2Single-language instructions
    • +3Description length 401: enough signal without eating the budget
    • +4Structure: 19 headings
    • +3Step-by-step instructions: 91 items
    • +4Has examples (1 code blocks)

    Quality base 70; lint remarks subtract, signals add up to 100. Result: 77.