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