# MDevSPICE Process Coverage

> Map organizational processes to the MDevSPICE process reference model and IEC 62304; document process coverage for assessment or audit.



Tags: MDevSPICE, Medical device, IEC 62304, Process coverage, Assessment


## Example Prompts

- Map our software processes to MDevSPICE and IEC 62304
- Draft a process coverage report for our MDevSPICE assessment

URL: https://rakenne.app/skills/mdevspice-process-coverage/index.md

Try this skill: https://rakenne.app/a/?skill=mdevspice-process-coverage



## Overview

Map organizational processes to the MDevSPICE process reference model and IEC 62304; document process coverage for assessment or audit.

## Getting Started

Add your source materials to the project workspace, then activate the *MDevSPICE Process Coverage* skill. The agent will guide you through the process step by step.

## Example Conversation

Below is an example of how a typical MDevSPICE Process coverage session unfolds. The agent confirms scope and drafts content aligned to MDevSPICE and IEC 62304.

> **You:** We need to prepare our MDevSPICE Process coverage document. Can you draft it based on our current procedures and evidence?
>
> **Agent:** I'll draft the Process coverage content. Do you have existing materials in the workspace (e.g. process lists, quality procedures, design history file references) I should use, or should I create a structure from the MDevSPICE reference?
>
> **You:** We have a procedure index and our DHF structure. Use those and the MDevSPICE process model reference.
>
> **Agent:** I've loaded the MDevSPICE process model (IEC 62304 process areas). I'll map your procedures and evidence to each process area and produce the Process coverage with coverage table and evidence references.

## Sample Output Excerpt

Below is a representative excerpt from an MDevSPICE Process coverage document.

---

### Scope and structure

This document covers [organisation]'s MDevSPICE Process coverage. It is aligned to the MDevSPICE process reference model and IEC 62304 (software development, maintenance, risk management, configuration management, problem resolution).

### Process / evidence (example)

| Process area | Implemented | Evidence / reference |
|--------------|--------------|----------------------|
| Software development | Yes | SOP-SWD-01; DHF section 4.2 |
| Software risk management | Yes | SOP-RM-01; risk file R-001 |
| Configuration management | Yes | SOP-CM-01; release records |

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## Extension and validation

This skill does not include custom validation tools. Elaboration is guided by the workflow in the skill and the MDevSPICE / IEC 62304 references. You can add extension tools later (e.g. to check process coverage or regulatory mapping) by editing the skill's `extension.ts`.


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