风险管理专家 (ISO 14971)

Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and pos...

This package appears coherent and implements ISO 14971 guidance with a benign local Python tool. Before installing or running: (1) verify the publisher/provenance (source/homepage are missing and _meta.json ownerId differs from the registry ownerId—this could mean it was repackaged), (2) review the included Python script yourself or run it in an isolated environment (it is a local CLI calculator and appears to make no network requests), (3) do not treat the content as a substitute for formal regulatory/legal review—have your compliance team validate templates and acceptance criteria, and (4) prefer skills from known/official sources when relying on them for regulatory work.

Type: OpenClaw Skill Name: risk-management-iso14971 Version: 1.0.0 The skill bundle provides a comprehensive and legitimate framework for medical device risk management according to ISO 14971. The included Python script (risk_matrix_calculator.py) is a safe, standalone utility for calculating risk levels and FMEA RPN values using standard libraries, with no network or file system access. The documentation and instructions in SKILL.md and the references directory are strictly professional in nature and contain no evidence of malicious intent, prompt injection, or data exfiltration.