IEC 62304 Software Lifecycle Author

Overview

Guided elaboration of medical device software lifecycle documentation per IEC 62304 — SDP, SOUP identification, SRS, design, verification/validation, and risk control integration.

Getting Started

Add your source materials to the project workspace, then activate the IEC 62304 Software Lifecycle Author skill. The agent will guide you through the process step by step.

Example Conversation

You: We need SDP, SRS, and V&V docs for our Class B medical device software. We use an open-source library (SOUP).

Agent: I’ll draft the Software Development Plan, SRS, and V&V documentation. I’ll identify the SOUP and add a risk assessment for it; safety class B is documented.

You: Run the validator. Agent: I ran check_iec62304_activity_deliverable_coverage. Lifecycle activities and deliverables present; SOUP risk assessment included. No warnings.

Sample Output Excerpt

SDP — Safety class B. SOUP — Library X v2.1; risk assessment: [reference]. Deliverables: SRS v1.0, Design Spec, SVVP, SVVR.

Built-in Validation Tools

check_iec62304_activity_deliverable_coverage checks for lifecycle deliverables (SDP, SRS, V&V) and SOUP risk assessment. Run on lifecycle document after drafting.