iso-13485-certification
Pass
Audited by Gen Agent Trust Hub on Jun 14, 2026
Risk Level: SAFE
Full Analysis
- [SAFE]: No malicious patterns detected. The skill's primary function is to assist in medical device Quality Management System (QMS) documentation, which is correctly reflected in its instructions and assets.
- [COMMAND_EXECUTION]: The skill includes a Python script (
scripts/gap_analyzer.py) designed to identify missing documentation by scanning a user-provided directory. The script uses standard library modules (argparse,json,pathlib) and does not contain dangerous execution patterns, network operations, or subprocess calls. - [DATA_EXPOSURE]: The gap analyzer script reads local files to perform its analysis. It only accesses the directory explicitly provided by the user via the
--docs-dirargument and does not attempt to access sensitive system files or exfiltrate data externally.
Audit Metadata