| 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).
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
