iso-13485-certification
Pass
Audited by Gen Agent Trust Hub on Apr 16, 2026
Risk Level: SAFECOMMAND_EXECUTION
Full Analysis
- [COMMAND_EXECUTION]: The skill utilizes a bundled Python script, 'scripts/gap_analyzer.py', to perform gap analysis on user-supplied documentation directories. This command execution is a core feature for evaluating Quality Management System (QMS) compliance.
- [SAFE]: The skill instructions and resources are focused on regulatory documentation guidance. No patterns of prompt injection, data exfiltration, or malicious persistence were detected. External references to the author's platform (www.k-dense.ai) are benign and serve for legitimate productivity suggestions.
Audit Metadata