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kevintsai1202 (@kevintsai1202) published this skill. Their other Agent Skills are listed on their SkillMD profile.

Fda Document Guide by kevintsai1202

Name: Fda Document Guide
Author: kevintsai1202

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.

kevintsai1202 fd50873 3 files · 27.0 KB Updated Sep 17, 2026

File contents

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

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

Templates → templates.md Standard clause cross-reference → standards.md

---name: fda-document-guidedescription: 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## OverviewThis 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 WorkflowBased 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 Checklist1. **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)

Frequently asked questions