← Back to Skills Marketplace
147
Downloads
0
Stars
0
Active Installs
1
Versions
Install in OpenClaw
/install medical-device-mdr-auditor
Description
Audit medical device technical files against EU MDR 2017/745 regulations.
Usage Guidance
This package appears to be an offline auditor implemented as a Python script; it does not request credentials or download external code. Before running: (1) review scripts/main.py locally (you already have it) and confirm there are no network calls or hidden behaviors (the reviewed portion showed none). (2) Do not run the tool against broad or sensitive directories — supply an explicit technical-file directory to avoid scanning unrelated files (and avoid PHI exposure). (3) Use the suggested safe checks first: python -m py_compile scripts/main.py and python scripts/main.py --help. (4) Treat outputs as heuristic: the script uses filename patterns and simple size checks and is not a substitute for legal/regulatory review. If you need higher assurance, run the script in a sandboxed environment or have a compliance expert review both the code and the generated report.
Capability Analysis
Type: OpenClaw Skill
Name: medical-device-mdr-auditor
Version: 1.0.0
The skill bundle is a legitimate tool designed to audit medical device technical documentation for EU MDR 2017/745 compliance. The core logic in `scripts/main.py` performs local file system scanning and keyword-based content validation using standard Python libraries (pathlib, re, json). No evidence of data exfiltration, network communication, or malicious execution (e.g., eval/os.system) was found. While the script reads file contents to verify regulatory requirements, it does so within the scope of its stated purpose, and the documentation in `SKILL.md` correctly describes the tool's behavior and risks.
Capability Assessment
Purpose & Capability
The name/description, SKILL.md, and scripts/main.py all describe and implement a directory-scanning auditor for EU MDR requirements (checking filenames, simple size heuristics, producing a report). Required binaries/env/configs are none, which matches an offline Python script. Minor oddity: requirements.txt lists dataclasses and enum (both in the standard library for targeted Python versions), but this is a benign packaging artifact.
Instruction Scope
The SKILL.md instructs the agent to run scripts/main.py and to validate input/output paths before running, which is within scope. Two practical cautions: (1) the script recursively scans the provided input path (Path.rglob), so pointing it at a high-level path (e.g., / or your whole user home) will enumerate many files — avoid passing broad/sensitive directories. (2) SKILL.md suggests editing an in-file CONFIG block; the code review did not show a clearly labeled CONFIG block in the truncated main.py, so there is mild mismatch between docs and code that should be confirmed before automated runs. Usage examples include an absolute user-specific workspace path (likely leftover from packaging) — harmless but signals it was packaged from a user machine.
Install Mechanism
No install spec; skill is instruction + included Python script. No network downloads or third‑party installers are required. This is the lowest-risk install model for a script-only skill.
Credentials
The skill requests no environment variables, no credentials, and no config paths. The script operates on a user-supplied filesystem path only, which is appropriate for a file-audit tool.
Persistence & Privilege
always is false and the skill does not request persistent system-wide privileges or attempt to modify other skills. Autonomous invocation is allowed (platform default) but not combined with any other concerning privileges or credentials.
How to Use
- Make sure OpenClaw is installed (local or Docker)
- Run the install command in chat:
/install medical-device-mdr-auditor - After installation, invoke the skill by name or use
/medical-device-mdr-auditor - Provide required inputs per the skill's parameter spec and get structured output
Version History
v1.0.0
Initial public release of the Medical Device MDR Auditor skill.
- Audits medical device technical files against EU MDR 2017/745 requirements.
- Checks for presence and completeness of critical documents, including Clinical Evaluation Reports, PMS and PMCF Plans, Risk Management, and other regulatory files.
- Supports single-file and batch audits with configurable input and output paths.
- Generates structured compliance reports, including audit findings and compliance status.
- Command-line interface with support for device classification, verbose output, and different output formats.
Metadata
Frequently Asked Questions
What is Medical Device MDR Auditor?
Audit medical device technical files against EU MDR 2017/745 regulations. It is an AI Agent Skill for Claude Code / OpenClaw, with 147 downloads so far.
How do I install Medical Device MDR Auditor?
Run "/install medical-device-mdr-auditor" in the OpenClaw or Claude Code chat to install it in one step — no extra setup required.
Is Medical Device MDR Auditor free?
Yes, Medical Device MDR Auditor is completely free, licensed under MIT-0. You can download, install and use it at no cost.
Which platforms does Medical Device MDR Auditor support?
Medical Device MDR Auditor is cross-platform and runs anywhere OpenClaw / Claude Code is available (cross-platform).
Who created Medical Device MDR Auditor?
It is built and maintained by AIpoch (@aipoch-ai); the current version is v1.0.0.
More Skills