Verification & Testing

From defining verification and testing plans that align with quality system requirements to implementing testing procedures based on industry standards, our comprehensive set of 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

Testing

We offer cost- and time-efficient testing capabilities for both software and electrical components of medical devices, in compliance with standards such as IEC 60601 and IEC 62304. Our approach integrates a wide range of testing methodologies to enhance effectiveness and reduce time-to-market, including:

• Software Testing: Component and integration testing fully aligned with IEC 62304. Ensures traceability from system requirements to software requirements, hazards, design, and verification.
• HMI Testing: Evaluation of human-machine interfaces, such as software applications used by clinicians.
• System Testing: Development and execution of test cases for various device functions.
• Hardware-in-the-Loop Testing: Simulation support for dynamic processes involving hardware components.
• Test Automation: Utilization of our custom-built System Validation Facility (SVF), which is easily configurable to project needs. The SVF enables rapid automation of test activities, supporting fully automated test script execution and comprehensive test campaign management.