fda-document-guide

name

fda-document-guide

description

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.

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).

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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

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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

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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 Standard clause cross-reference → standards.md