MDevSPICE Regulatory Readiness Narrative

Overview

Draft a regulatory readiness narrative for FDA (21 CFR 820), EU MDR, and IEC 62304; document evidence and alignment for audit or submission.

Getting Started

Add your source materials to the project workspace, then activate the MDevSPICE Regulatory Readiness Narrative skill. The agent will guide you through the process step by step.

Example Conversation

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

You: We need to prepare our MDevSPICE Regulatory readiness narrative document. Can you draft it based on our current procedures and evidence?

Agent: I’ll draft the Regulatory readiness narrative 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 Regulatory readiness narrative with coverage table and evidence references.

Sample Output Excerpt

Below is a representative excerpt from an MDevSPICE Regulatory readiness narrative document.

Scope and structure

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

Process / evidence (example)

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.