Verification & Validation

From defining verification and validation plans that match quality system requirements to the testing procedures which must be implemented based on industry standards. Our comprehensive set of V&V services for the medical devices industry includes:

Verification

An activity which includes the whole system and software. A verification plan provides assurance that the design process has been well scoped, is progressing according to expectations, and that the product meets the needs of stakeholders. The main objectives are:

• Selecting verification strategies and techniques
• Choosing the most appropriate software test equipment
• Documenting verification activities in detail
• Evaluating verification results
• Monitoring risk control requirements
• Identifying and maintaining the roles and responsibilities of those involved in the verification and test processes

Validation

Cost and time-effective testing capacities for both software and electrical components of medical devices, in line with standards such as IEC 60601 and IEC 62304. Our approach incorporates a comprehensive set of tests and methodologies designed to increase effectiveness and reduce time costs, including test automation, fault injection, robustness testing, regression testing, hardware and software in the loop testing, system testing, component testing, and more:

• Software testing. Component and integration testing in full conformance with the provisions of IEC 62304. Traceability from system requirements to software requirements, hazards, design, and verification.
• HMI testing. Testing of human-machine interfaces such as software applications running on consoles operated by doctors.
• System testing. Definition of test cases for different device functions and execution of test procedures.
• Hardware-in-the-loop testing. Support for hardware-in-the-loop simulations of dynamic processes.
• Test automation. Use of our bespoke System Validation Facility (SVF), which can be easily customised as per project requirements, enabling a fast response time to test automation activities. The SVF supports the fully automated execution of test scripts and completes automated checks to create comprehensive test campaigns.