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Mdr 745 Specialist

v2.1.1

EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Ann...

⭐ 1· 1.7k·7 current·7 all-time
byAlireza Rezvani@alirezarezvani
MIT-0
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LicenseMIT-0 · Free to use, modify, and redistribute. No attribution required.
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Benign
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Benign
high confidence
✓
Purpose & Capability
Name and description (EU MDR specialist) match the manifest: SKILL.md contains classification, technical documentation, clinical evidence and PMS guidance, and the included scripts/references implement a gap-analysis and templates appropriate to that purpose. The presence of a local Python 'mdr_gap_analyzer.py' is coherent with a compliance-assessment tool. The only minor provenance issue is that the skill's source/homepage is unknown (no publisher link), but that does not make the requested capabilities disproportionate.
✓
Instruction Scope
SKILL.md instructions are scoped to MDR classification, documentation and evidence workflows. The instructions do not direct the agent to read unrelated system files, request environment variables, or post data to external endpoints. They don't give open-ended permissions ('gather whatever context you need').
✓
Install Mechanism
No install spec (instruction-only) — lowest install risk. A single Python script is included but there is no download-from-URL, package installation, or extract step. Running the script locally would require Python, which is typical and reasonable for this tool.
✓
Credentials
The skill declares no required environment variables, credentials, or config paths. The included code and docs do not reference secrets or external service keys. Requested access is proportional to the stated functionality.
✓
Persistence & Privilege
Flags show default privileges (always: false, agent invocation enabled). The skill does not request permanent/force-included presence and does not appear to modify other skills or system-wide agent settings.
Assessment
This skill appears internally consistent and implements what it claims: MDR guidance, templates, and a local gap-analysis script. Before installing or running it: (1) verify the author's identity/source if you require provenance (there's no homepage listed), (2) review the Python script yourself or run it in a sandboxed environment if you have concerns, (3) do not supply unrelated secrets or system credentials to the skill, and (4) if you will rely on the output for regulatory submissions, have a qualified clinical/regulatory evaluator review the results for completeness and correctness.

Like a lobster shell, security has layers — review code before you run it.

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License

MIT-0
Free to use, modify, and redistribute. No attribution required.
Termshttps://spdx.org/licenses/MIT-0.html

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