# IEC 62304 Software Lifecycle Author

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



Tags: IEC 62304, Medical Device, Software, Lifecycle, Compliance


## Example Prompts

- Draft Software Development Plan and SRS per IEC 62304
- Identify SOUP and document risk assessment
- Check that each lifecycle activity has a deliverable

URL: https://rakenne.app/skills/iec62304-software-lifecycle-author/index.md

Try this skill: https://rakenne.app/a/?skill=iec62304-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.

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## 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.


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