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Mdr 745 Specialist
by
Alireza Rezvani
· GitHub ↗
· v2.1.1
· MIT-0
1747
Downloads
1
Stars
8
Active Installs
2
Versions
Install in OpenClaw
/install mdr-745-specialist
Description
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Ann...
Usage Guidance
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.
Capability Analysis
Type: OpenClaw Skill
Name: mdr-745-specialist
Version: 2.1.1
The skill bundle is a specialized tool for EU MDR 2017/745 medical device compliance. The Python script (mdr_gap_analyzer.py) is a standard CLI utility for performing gap assessments based on user input, containing no network activity, file system modifications, or obfuscated code. The documentation files (SKILL.md and references/) provide legitimate regulatory guidance and templates without any evidence of prompt injection or malicious instructions.
Capability Assessment
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.
How to Use
- Make sure OpenClaw is installed (local or Docker)
- Run the install command in chat:
/install mdr-745-specialist - After installation, invoke the skill by name or use
/mdr-745-specialist - Provide required inputs per the skill's parameter spec and get structured output
Version History
v2.1.1
v2.1.1: optimization, reference splits
v1.0.0
- Initial release of mdr-745-specialist: an EU MDR 2017/745 compliance skill for medical device manufacturers.
- Supports device classification (Annex VIII), technical documentation (Annex II/III), clinical evidence (Annex XIV), and post-market surveillance.
- Covers software rules, EUDAMED integration, UDI labeling, notified body engagement, and PMS/PMCF processes.
- Provides structured workflows, checklists, and example classifications to guide MDR compliance.
- Includes reference documentation for Annex VIII classification and conformity assessment routes.
Metadata
Frequently Asked Questions
What is Mdr 745 Specialist?
EU MDR 2017/745 compliance specialist for medical device classification, technical documentation, clinical evidence, and post-market surveillance. Covers Ann... It is an AI Agent Skill for Claude Code / OpenClaw, with 1747 downloads so far.
How do I install Mdr 745 Specialist?
Run "/install mdr-745-specialist" in the OpenClaw or Claude Code chat to install it in one step — no extra setup required.
Is Mdr 745 Specialist free?
Yes, Mdr 745 Specialist is completely free, licensed under MIT-0. You can download, install and use it at no cost.
Which platforms does Mdr 745 Specialist support?
Mdr 745 Specialist is cross-platform and runs anywhere OpenClaw / Claude Code is available (cross-platform).
Who created Mdr 745 Specialist?
It is built and maintained by Alireza Rezvani (@alirezarezvani); the current version is v2.1.1.
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