iso-13485-certification

Pass

Audited by Gen Agent Trust Hub on Apr 16, 2026

Risk Level: SAFE
Full Analysis
  • [SAFE]: The skill's primary purpose is to assist with regulatory compliance documentation. All scripts and templates analyzed are consistent with this purpose.
  • [COMMAND_EXECUTION]: The skill includes a Python script (scripts/gap_analyzer.py) designed to be run by the user. Analysis of the source code confirms it only performs local file system operations (reading documents and writing a JSON report) and uses only standard Python libraries.
  • [DATA_EXFILTRATION]: There are no network operations, API calls, or telemetry features detected in the script or instructions. All analysis is performed locally on the user's machine.
  • [CREDENTIALS_UNSAFE]: No hardcoded API keys, tokens, or credentials were found in the templates or scripts. The templates correctly use placeholders like [NAME] or [DATE] for user input.
  • [PROMPT_INJECTION]: The instructions in SKILL.md are descriptive and provide clear guidance for the agent's behavior without attempting to override safety filters or system prompts.
  • [INDIRECT_PROMPT_INJECTION]: While the skill processes user-provided documentation through its gap analysis script, the script's functionality is limited to keyword matching and does not involve executing the content of those files. There is a theoretical surface for the agent to encounter instructions inside user documents, but the risk is managed by the specific scope of the QMS task.
Audit Metadata
Risk Level
SAFE
Analyzed
Apr 16, 2026, 10:49 PM