How to master verification and validation ?

In medical device development, two questions can define the success of your entire design control process:

• Did you design it right?

• Or did you design the right thing?

They may sound similar, but they point to two very different kinds of confidence. One ensures your design meets its requirements. The other ensures it meets real-world needs. Together, they form the backbone of effective design control — and they’re known as Verification and Validation.

Designing it right: Verification

Verification is where your team proves that the design you created actually meets the requirements you set out in the beginning.

It’s a technical process: you inspect, test, and analyze each stage of development to confirm that every design output matches its corresponding input. Whether it’s through inspection, simulation, or testing, the goal is always the same : to provide objective evidence that your specifications have been fulfilled.

In other words, verification answers the question: did we build the device right?

It’s a systematic and structured step, often taking place throughout the development cycle. The more complex the device, the more varied and comprehensive your verification methods need to be.

But even a perfectly verified design doesn’t guarantee success, because it only tells you that the product matches the plan. It doesn’t tell you whether the plan itself was right.

Designing the right thing: Validation

That’s where validation comes in.

Validation is about stepping outside the lab and into the real world. It confirms that your device not only works as designed, but that it truly meets user needs and performs safely and effectively under real conditions.

Here, you involve real users in intended use environments, testing how the device behaves in practice. It’s less about engineering precision and more about understanding context, usability, and performance in the situations that matter most.

So if verification asks, “Did we build it right?”, validation asks, did we build the right device?

Together, these two processes ensure that your design is both technically sound and clinically meaningful.

Why clear criteria matter

The most common pitfall teams face is starting V&V work without defining clear criteria up front. Without specific success measures, testing becomes guesswork.

When you establish your verification and validation criteria early, you create a shared understanding of what success looks like. Every test, inspection, and analysis has a clear purpose and every outcome can be objectively evaluated. This alignment not only strengthens your technical process but also builds confidence across teams, regulators, and users alike.

The thread that connects it all: Traceability

Even the most thorough verification and validation efforts can lose their impact without traceability. If you can’t connect requirements to outputs, or tests to the risks they mitigate, your design control process remains fragile. A traceability matrix solves this by linking every element from user needs and requirements to verification results and validation evidence.

It provides visibility into how each decision supports compliance, safety, and performance. More importantly, it ensures that nothing is lost or overlooked, no matter how complex the project becomes.

How Matrix Req makes it simple

This is exactly where Matrix Req helps MedTech teams stay ahead.

With Matrix Req, you can capture, link, and update dynamically every requirement, output, and test result in one place. Your traceability remains alive throughout the entire product lifecycle, not locked away in static spreadsheets or outdated documents.

Teams can collaborate confidently, auditors can see a clear line from user need to final validation, and design control becomes something manageable instead of overwhelming.

Today, more than 300 MedTech companies use Matrix Req to keep their design verification, validation, and traceability fully connected and audit-ready.

Right design, designed right

Verification ensures you designed it right.

Validation ensures you designed the right thing.

Traceability ensures you can prove it every step of the way.

With Matrix Req, all three come together naturally, helping you build devices that are not just compliant, but truly designed for the people who depend on them.