REG-IEC62304

What problem does it solve?

This Skill provides comprehensive guidance to ensure medical device software adheres to the stringent lifecycle controls mandated by IEC 62304, minimizing regulatory risk and enhancing product safety.

Core Features & Use Cases

• Lifecycle Planning: Implement robust Software Development Plans (SDPs) tailored to software class (A, B, C).
• Traceability: Establish and maintain bidirectional traceability between requirements, design, code, and tests.
• SOUP Management: Control and document Software of Unknown Provenance (SOUP) to mitigate risks.
• Verification & Validation: Ensure thorough unit, integration, and system testing with documented procedures and results.
• Use Case: When developing a Class C medical device, use this Skill to generate the required SDP, document traceability matrices, manage third-party libraries as SOUP, and create detailed test plans and reports, ensuring compliance with IEC 62304.

Quick Start

Apply the REG-IEC62304 skill to ensure all software units have bidirectional traceability to requirements and tests.