Systems Engineering | Test & Verification
Our systems engineers ensure inter-operability of all systems/subsystems and test/verify the product against all requirements and risk controls, perform summative studies, obtain certification and provide regulatory input.
- Requirements planning and execution
- Product and system architecture
- Systems engineering and integration planning and execution
- Risk management
- Certification process
- Managing controlled builds
- Verification and validation planning
- Trace matrix
Our Areas of Expertise
|Requirements||Develop product, system, software and sub-system requirements. Develop product and system architecture.|
|Risk Management||Using 14971, develop Hazard Analysis, Risk Analysis, Design Failure Mode and Effect Analysis (dFMEA), and FTA.|
|Systems Engineering||System Technical Lead, interface and integration management (sub-systems, software/firmware/hardware/mechanical), Oversees agency certification. Structures and manages development sequence (alpha, beta, release).|
|Test and Verification||Verification planning, protocol development against requirements, EVT, DVT, regression tests, reports, Risk Management File input, 510(k) input.|
|Trace Matrix||Full trace between requirements and verification and validation. See diagram below.|
We maintain a trace matrix to ensure that all requirements defined for a system are tested. The trace matrix offers a tool both for the system/test team, to ensure that requirements are not lost during verification and validation of the product, and for auditors, to review the documentation.
The trace matrix is usually developed along with the requirements (user, product, software, and system/sub-system). As Design Specifications and Test Protocols are developed, the trace matrix is updated to include the updated documents. Requirements are typically traced to the specific test step in the verification and validation protocol in which they are tested.