# Fda Document Guide

> FDA medical device software certification document generation guide. Based on EN 62304, EN ISO 14971, and ISO/TR 24971 standards, helps generate 13 required regulatory documents (Documentation Level Evaluation, Software Risk Management Plan, Hazard Analysis, SRS, SDS, V&V testing documents, Risk Management File, etc.). Use this skill whenever the user mentions FDA/CE/MDR certification, software risk management, IEC 62304, ISO 14971, hazard analysis, software verification and validation (V&V), medical device software submissions, or asks about any regulatory standard requirements. Standard clauses are built into the references/ directory and can be referenced directly without any external connection.

- Skill: `kevintsai1202/fda-document-guide` (Agent Skill, multi-file: 3 files)
- Install (CLI): `npx skillmds@latest add kevintsai1202/fda-document-guide`
- Raw SKILL.md: https://api.skillmd.com/api/skills/kevintsai1202/fda-document-guide/raw
- Safety review: pending
- Works with: Claude Code, Claude.ai, OpenAI Codex
- Category: Docs & Writing
- Author: kevintsai1202 (https://skillmd.com/u/kevintsai1202)
- Updated: 2026-09-17
- Page: https://skillmd.com/skills/kevintsai1202/fda-document-guide

---


# FDA Medical Device Software Document Generation Guide

## Overview

This skill systematically generates regulatory documents for medical device software following FDA/CE certification workflows.
All standard clauses are built into `references/` and work standalone.

### Three Core Standards

| Standard | Description | Index Path |
| :------- | :---------- | :--------- |
| EN 62304:2006+A1:2015 | Medical Device Software Life-Cycle Processes | `references/EN_62304/_index.md` |
| EN ISO 14971:2019+A11:2021 | Medical Devices Risk Management | `references/EN_ISO_14971/_index.md` |
| ISO/TR 24971:2020 | Guidance on the Application of ISO 14971 | `references/ISO_TR_24971/_index.md` |
| Document Relationship Index | Dependency map for all 13 documents | `references/index.md` |

Each standard directory contains `_index.md` (chapter index) and per-chapter `content.md` (full clause text).

---

## Document Generation Workflow

Based on `references/index.md`, 13 documents must be produced in this sequence:

```
Product Specification (source material)
        │
        ▼
(1) Documentation Level Evaluation
        │
        ▼
(2) SW Development, Config Mgmt & Maintenance Practices
        │
        ▼
(3) Software Risk Management Plan ──────────────────┐
        │                                            │
        ▼                                            │
(4) Software Hazard Analysis ────────────────────────┤
        │                                            │
        ▼                                            │
(5) Software Requirements Specification (SRS)        │
        │                                            │
        ▼                                            │
(6) System & Software Architecture Diagram           │
        │                                            │
        ▼                                            │
(7) Software Description                             │
        │                                            │
        ▼                                            │
(8) Software Design Specification (SDS)              │
        │                                            │
        ▼                                            │
(9) Software Testing (V&V)                           │
        │                                            │
        ▼                                            │
(10) Software Hazard Report ─────────────────────────┤
        │                                            │
        ▼                                            ▼
(11) Software Version History            (13) Risk Management File
        │                                    ← aggregates (3)+(4)+(10)
        ▼
(12) Unresolved Software Anomalies
```

---

## How to Use

### 1. With Source Material

**Step 1: Determine documentation level**
- Read the Product Specification
- Determine FDA Documentation Level (Minor / Moderate / Major concern)
- Generate (1) Documentation Level Evaluation

**Step 2: Generate documents in sequence**
- Apply the template from `templates.md` for the target document
- Fill in content from source materials
- Reference the relevant standard clauses (see `standards.md`)

### 2. Without Source Material (Framework Mode)

- Use the document framework directly from `templates.md`
- Mark fields to be filled with `[TODO: ...]`
- Explain fill-in requirements and corresponding standard references for each field

---

## Startup Checklist

1. **Identify which document(s) the user needs** (numbers 1–13)
2. **Confirm whether source material exists** (Product Spec, prior-stage documents)
3. **Look up the relevant standard clauses** (see the quick-reference table in `standards.md`)
4. **Apply the matching template from `templates.md`**

Templates → [templates.md](templates.md)
Standard clause cross-reference → [standards.md](standards.md)