Medical Device MDR Auditor

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

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.

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.