Software Verification and Validation (V&V)
Software verification and validation is mandated both by the FDA and CE for all software in the medical devices. We help you perform all of the software V&V activities, including developing all of the software documentation (according to need) for the medical devices, production facilities, clean rooms, ERP, MRP and logistics systems:
- URS (User Requirements Specification)
- SRS (Software Requirements Specification)
- SDD (Software Design Document)
- STP (Software Test Plan)
- STD (Software Test Description)
- STR (Software Test Report)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Off the shelf (OTS) software validation