What problem does it solve? Medical device software must meet strict safety and regulatory standards like IEC 62304, YY/T 0664, and NMPA registration requirements, but manually auditing code against these rules is slow and error-prone. This Skill automates the review of code safety, cybersecurity, and quality against those standards. ## Core Features & Use Cases - Safety Classification & Audit Workflow: Determines the IEC 62304/YY/T 0664 software safety class (A/B/C) first, then applies the matching review rigor for documentation, testing coverage, and traceability. - Security & Quality Defect Detection: Flags hardcoded credentials, unencrypted PHI, injection flaws, race conditions, integer overflows, missing timeouts, and low test coverage against defined thresholds. - China NMPA Compliance Checks: Verifies conformity with GB 9706.1-2020, YY/T 0664-2020, cybersecurity guidance, and data protection laws, producing a structured findings report with severity levels. - Use Case: A team developing infusion pump firmware (Class C) submits their C++ codebase for review and receives a report listing critical issues with file/line references, plus a compliance status summary for IEC 62304 and NMPA requirements. ## Quick Start Review this medical device software code for IEC 62304 and NMPA compliance and list any critical safety or security issues.
