Capability Highlights

  • 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

Trace Matrix

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.

Our Areas of Expertise

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 product certification and provide regulatory input.
Systems Engineering | Test & Verification
Aproio: we analyze, design, build & test medtech and other highly regulated products