# MDevSPICE Software Problem Resolution Process

> Document and evidence the software problem resolution process per IEC 62304 and MDevSPICE: problem reporting, analysis, root cause, corrective action, and link to maintenance and CAPA.



Tags: MDevSPICE, Medical device, IEC 62304, Problem resolution, CAPA


## Example Prompts

- Document our software problem resolution process for MDevSPICE assessment
- Draft the problem resolution procedure and problem report template for our SaMD
- Prepare problem resolution and CAPA evidence for FDA and MDR audit

URL: https://rakenne.app/skills/mdevspice-software-problem-resolution/index.md

Try this skill: https://rakenne.app/a/?skill=mdevspice-software-problem-resolution



## Overview

Document and evidence the software problem resolution process per IEC 62304 and MDevSPICE: problem reporting, analysis, root cause, corrective action, and link to maintenance and CAPA.

## Getting Started

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

## Example Conversation

Below is an example of how a typical MDevSPICE Software problem resolution process session unfolds. The agent confirms scope and drafts content aligned to MDevSPICE and IEC 62304.

> **You:** We need to prepare our MDevSPICE Software problem resolution process document. Can you draft it based on our current procedures and evidence?
>
> **Agent:** I'll draft the Software problem resolution process 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 Software problem resolution process with coverage table and evidence references.

## Sample Output Excerpt

Below is a representative excerpt from an MDevSPICE Software problem resolution process document.

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### Scope and structure

This document covers [organisation]'s MDevSPICE Software problem resolution process. 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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