iso-13485-certification
Pass
Audited by Gen Agent Trust Hub on Jun 26, 2026
Risk Level: SAFECOMMAND_EXECUTION
Full Analysis
- [SAFE]: The skill functions as a documentation assistant for medical device Quality Management Systems (QMS), providing templates and clause-by-clause guidance on ISO 13485:2016 requirements.
- [COMMAND_EXECUTION]: The skill includes a local Python utility,
scripts/gap_analyzer.py, which is used to perform gap analysis on user-provided documentation. This script scans files in a specified directory for keywords related to mandatory ISO procedures. The script uses only standard Python libraries (os, sys, argparse, json, pathlib, typing, datetime), performs no network operations, and contains no obfuscated or dynamic execution logic. - [PROMPT_INJECTION]: A review of the instructions and metadata revealed no patterns associated with prompt injection, safety bypasses, or instruction overrides.
- [DATA_EXFILTRATION]: There are no hardcoded credentials, access to sensitive system paths (such as .ssh or .aws), or mechanisms for network exfiltration identified in the skill scripts or templates.
Audit Metadata