pm-gamma-medical-compliance

What problem does it solve?

Helps PACS/RIS product managers and regulatory owners systematically determine NMPA software change classifications, prepare complete registration documentation, maintain DICOM conformance statements, and meet security and PHI protection requirements for medical imaging products.

Core Features & Use Cases

• Change Classification & Risk Assessment: Step-by-step method to classify software updates (major, minor, maintenance) per YY/T 0664 and identify high-risk scenarios such as AI features or core algorithm changes.
• Registration Document Checklist & Version Control: Ready checklist of required technical files (SDD, network security, clinical evaluation, algorithm validation) and guidance on versioning and approval workflows for NMPA submissions.
• DICOM Conformance & Testing Guidance: Procedures for updating DICOM Conformance Statements, SOP Class risk grading, multi-modality compatibility matrices, and recommended validation tools and test suites.
• Use Case: When adding an AI-assisted diagnostic module to a PACS, use this Skill to decide if re-registration is required, compile the document list, and update DICOM conformance and security controls before deployment.

Quick Start

Evaluate a proposed software change that adds an AI-assisted image analysis feature and produce a compliance assessment, required registration document checklist, DICOM conformance update steps, and security/PHI considerations.