Software Verification & Validation Plan (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 planning software verification activities per IEC 62304 Clauses 5.5–5.7 (unit, integration, and system testing), extended with validation planning consistent with FDA software validation expectations. It defines what is tested, how, by whom, and against which acceptance criteria.
What is included
- Verification strategy scaled to software safety class
- Unit verification acceptance criteria and procedures (5.5)
- Integration and integration testing plan (5.6)
- Software system test plan, environments, and tools (5.7)
- Pass/fail criteria, regression testing, and anomaly handling rules
- Roles, independence, and test documentation requirements
- Traceability hooks to requirements and risk controls
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.