Design Documentation (SAD/SDD)

What problem does it solve?

This Skill addresses the challenge of creating and maintaining comprehensive Software Architecture (SAD) and Design Descriptions (SDD) that are crucial for medical device safety, traceability, and regulatory compliance.

Core Features & Use Cases

• Architecture Documentation: Guides the creation of SAD documents detailing components, interfaces, data flows, and safety segregation.
• Design Detailing: Provides requirements for module-level design documentation for Class B/C software, including algorithms, state machines, and error handling.
• Traceability: Emphasizes linking design elements to requirements, hazards, and tests.
• SOUP Management: Includes guidance on documenting Software of Unknown Provenance (SOUP).
• Use Case: When developing a new Class C medical device, use this Skill to ensure your SAD and SDD meet IEC 62304 and ISO 14971 requirements, including clear documentation of safety boundaries and SOUP components.

Quick Start

Generate comprehensive design documentation for a Class C medical device software component, ensuring traceability to requirements and hazards.