Medical Device Software V&V Training Course + SW Documentation Kit

Learn it, then write it

The course walks through the software file clause by clause. The kit gives you the documents. Taken together, the workbook you fill in during the course stops being a list of gaps and becomes a list of documents you already have.

What you get

The course — 2 h 30, four modules

• Where the requirements live: ISO 13485 §7.3, 21 CFR 820.30, IEC 62304, IEC 82304-1
• Safety classification, and the Amendment 1 change that invalidated a common strategy
• Clause 5 end to end: planning, SOUP, requirements, architecture, detailed design, units, integration, system testing, release
• Maintenance, software risk management, configuration management, problem resolution
• Validation of a health software product under IEC 82304-1
• Test after each module, final test, certificate of completion
• Software file gap analysis workbook, transcripts, slide handouts

The SW Documentation Kit — 12 templates, 9 Word + 3 Excel

• Software Development Plan (clause 5.1)
• Software Requirements Specification (5.2)
• Architecture & Detailed Design (5.3–5.4)
• Traceability Matrix — Excel
• SOUP List & Evaluation Record — Excel
• V&V Plan and V&V Report (5.5–5.8)
• Release & Configuration Management Record (5.8, 8)
• Problem Resolution & Anomaly Log — Excel (9)
• Cybersecurity Risk Assessment & Threat Model
• Cybersecurity Management Plan
• Vulnerability Disclosure Policy

Why together

Writing from a template is not faster because it saves typing. It is faster because the structure is the part that is hard to get right — and the course is what tells you why each section is there and what a reviewer will look for inside it.

Both are lifetime access, and both are yours to keep.