SW Documentation Kit Gold

What it is: the complete software file for AI/ML-enabled medical devices and SaMD, in one coordinated set. Twenty-three professionally drafted templates across three modules — the full IEC 62304 software lifecycle, the complete AI/ML documentation set built on the IMDRF Good Machine Learning Practice principles, and the cybersecurity file expected under Regulation (EU) 2017/745. Everything a Notified Body or FDA reviewer expects for machine-learning-based software, from development plan to postmarket AI performance monitoring.

What is included

Module 01 — Software Lifecycle (IEC 62304), 9 templates:

• Software Development Plan — Clause 5.1, scaled by safety class A/B/C
• Software Architecture & Detailed Design — Clauses 5.3–5.4
• Software Requirements Specification — Clause 5.2
• Software Traceability Matrix (Excel) — requirements ↔ design ↔ risk controls ↔ tests
• SOUP List & Evaluation Record (Excel) — SBOM-friendly
• Software Verification & Validation Plan — Clauses 5.5–5.7
• Software Verification & Validation Report — Clause 5.8
• Software Release & Configuration Management Record — Clauses 5.8 and 8
• Problem Resolution & Anomaly Log (Excel) — Clause 9

Module 02 — AI/ML (IMDRF GMLP spine), 11 templates:

• Master Index & Conformity Matrix (Excel) — 5 sheets: kit index plus GMLP, Transparency, Regulatory and Jurisdiction matrices
• AI Development & Lifecycle Plan — IEC 62304 + Health Canada 9-stage ML lifecycle
• Data Governance & Bias Management Plan — GMLP P1–P3
• Model Validation & Performance Report — with subgroup performance analysis
• AI Risk Management Plan & Report — ISO 14971 + AAMI CR34971
• Predetermined Change Control Plan (PCCP) — FDA + Health Canada nomenclature
• Human Oversight & Transparency Plan — EU AI Act Articles 13–14
• Postmarket AI Performance Monitoring Plan — drift detection and re-training triggers
• Clinical Evaluation Plan — AI-Augmented, with [AI MODULE] markers
• Clinical Evaluation Report — AI-Augmented
• SOP — AI/ML Model Development & Lifecycle — ISO 13485 §7.5

Module 03 — Cybersecurity (MDCG 2019-16, IEC 81001-5-1), 3 templates:

• Cybersecurity Risk Assessment & Threat Model — STRIDE-based, CVSS-compatible scoring
• Cybersecurity Management Plan — secure development lifecycle and post-market security monitoring
• Vulnerability Disclosure Policy — coordinated disclosure per ISO/IEC 29147 and 30111

Format

19 Microsoft Word .docx files + 4 Excel .xlsx files (all fully editable) + slim README with usage instructions. Delivered as a single ZIP organised in three module folders. Instant download after purchase.

Why Gold?

Regulators expect AI-enabled software to carry the AI lifecycle file on top of — not instead of — the IEC 62304 documentation. Gold delivers both, coordinated: the AI Development Plan builds on the IEC 62304 Development Plan, SOUP and SBOM tracking feed the security risk assessment, and the PCCP links to configuration management and the anomaly log. Save €199 vs buying the SW Documentation Kit (€499) and the AI/ML Kit (€499) separately: €799 instead of €998.

Not building AI-enabled software? The SW Documentation Kit (12 templates, €499) covers the full IEC 62304 lifecycle plus cybersecurity.