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