IEC 62304 Medical Device Software Lifecycle

A modular skill set for AI coding agents working on medical device software development. Provides structured guidance aligned to IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), FDA 21 CFR Part 820, and EU MDR (Medical Device Regulation) standards. The skill ensures that software development activities produce the documentation, testing, and traceability artifacts required for regulatory submissions and quality system compliance.

Quick Install

npx skills add Open-Medica/open-medical-skills --skill iec-62304-compliance

What It Does

• Software safety classification: Guides determination of IEC 62304 software safety class (Class A, B, or C) based on severity of hazardous situations that could result from software failure, which in turn defines the rigor of required development activities
• Lifecycle process mapping: Maps each phase of the software development lifecycle (planning, requirements, architecture, detailed design, implementation, integration/testing, release, maintenance) to IEC 62304 clause requirements, identifying required deliverables and review gates
• Documentation template generation: Produces compliant document templates for Software Development Plan, Software Requirements Specification, Software Architecture Document, Software Detailed Design, Software Unit Test Plan, Software Integration Test Plan, and Software Release documentation
• Risk management integration: Links software development activities to ISO 14971 risk management processes, ensuring that software-related hazards are identified, risk controls are implemented in code, and traceability from hazard analysis through to verification of risk control measures is maintained
• Change control and maintenance: Provides guidance on IEC 62304 Clause 6 (Software Maintenance Process) including problem resolution, change request evaluation, regression analysis requirements, and re-release documentation for post-market software modifications

Clinical Use Cases