Software Documentation Bundle Kit

What it is: the complete IEC 62304 software lifecycle file plus the cybersecurity documentation expected under Regulation (EU) 2017/745, in one coordinated set. Twelve professionally drafted templates covering software development, verification, maintenance, and security — the full documentation package Notified Bodies expect for medical device software (safety Class A, B, or C) and SaMD.

What is included

Cybersecurity (MDCG 2019-16, IEC 81001-5-1):

• Cybersecurity Risk Assessment & Threat Model — STRIDE-based, CVSS-compatible scoring, ISO 14971 interface
• Cybersecurity Management Plan — secure development lifecycle and post-market security monitoring
• Vulnerability Disclosure Policy — coordinated disclosure per ISO/IEC 29147 and ISO/IEC 30111

IEC 62304 software lifecycle:

• Software Development Plan — Clause 5.1, scaled by safety class
• Software Architecture & Detailed Design — Clauses 5.3–5.4, including SOUP requirements and segregation
• Software Requirements Specification — Clause 5.2, all requirement categories with verification criteria
• Software Traceability Matrix (Excel) — requirements ↔ design ↔ risk controls ↔ tests, per 5.1.1 and 7.3.3
• SOUP List & Evaluation Record (Excel) — Clauses 5.3.3–5.3.4, 7.1.2–7.1.3, 8.1.2, SBOM-friendly
• Software Verification & Validation Plan — Clauses 5.5–5.7, unit to system testing
• Software Verification & Validation Report — Clause 5.8, residual anomaly evaluation and release decision
• Software Release & Configuration Management Record — Clauses 5.8 and 8, version control and archiving
• Problem Resolution & Anomaly Log (Excel) — Clause 9, from problem report to trend analysis

Format

9 Microsoft Word .docx files + 3 Excel .xlsx files (all fully editable). Delivered as a single ZIP. Instant download after purchase.

Why the bundle?

All 12 templates share consistent structure, terminology, and cross-references — requirement IDs in the SRS flow into the Traceability Matrix, SOUP items link to the security risk assessment, and the anomaly log feeds the release record. Save 40% vs buying individually: EUR 499 vs EUR 828.