Software Verification & Validation Report (IEC 62304)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
What it is: a professionally drafted Word template for reporting the results of software verification and validation activities executed under the V&V Plan, supporting the release decision required by IEC 62304 Clause 5.8. It consolidates test results, anomalies, and the objective evidence Notified Bodies expect.
What is included
- Summary of executed unit, integration, and system tests vs plan
- Test results with pass/fail status and deviations
- Anomalies found, resolution status, and links to the problem log
- Evaluation of known residual anomalies (5.8.2–5.8.3)
- Verification of completeness of lifecycle activities (5.8.1)
- Release recommendation and approval signatures
- Traceability confirmation statement
Format
1 Microsoft Word .docx file (fully editable) + slim README with usage instructions. Delivered as a small ZIP. Instant download after purchase.
Need the full lifecycle?
This is 1 of 12 templates in the IEC 62304 & Cybersecurity Documentation Kit.
€69.00
Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.