Design Verification & Validation

Did you design it right? Or did you design the right thing?

These two questions might sound similar, but in the world of medical device development, they define two entirely different phases:

Verification and Validation. ↴

▣ Verification is about making sure the design meets the requirements, you examine, test, and review every stage to confirm that the output matches what was initially planned.

▣ Validation, on the other hand, proves that the final device actually meets user needs and works as intended in real-world scenarios.

However, if you can’t link your requirements to outputs, or your tests to the risks they mitigate, you’re vulnerable.

A good traceability matrix helps you track every input, output, and piece of V&V evidence making your design control airtight, and your audit readiness bulletproof.

That’s where Matrix Req come in. We help MedTech teams stay traceable.

Download our guide now for more details!