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
The reporting counterpart to the V&V Plan. It records the test execution summary, per-test-case results (PASS/FAIL/BLOCKED/NOT RUN), security and vulnerability-scan results, SOUP verification outcomes, any documented deviations from the plan, and the formal release-criteria verification that supports the signed V&V conclusion and release-gate decision. Fully editable Word template.
€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.