A medical device must meet defined requirements, function under real-world conditions, and be properly documented. That is verification.
At B&W, we view verification as an integral part of the development process itself. Experience shows that relevant issues rarely arise only during testing—that’s where they become apparent. They arise earlier, for example, in unclear requirements, in poorly defined interfaces, and in a lack of feedback between mechanics, electronics, and software.
Verification answers a clear question: Have we developed the product correctly?
The goal is to demonstrate that defined requirements are actually met. This applies to dimensions and tolerances, functions, load-bearing capacity, material behavior, software logic, interfaces, and documented performance data. In medical technology, this verification is essential because even small deviations can quickly have major consequences.
Verification clearly shows whether a requirement is met or not. It provides an unambiguous result and highlights gaps. This begins with requirements that are difficult to verify later on and continues when risk management and testing strategies run parallel to each other rather than building upon one another. If, in addition, prototypes are available but their testability was never consistently considered, this can lead to a critical phase in the project. In the worst case, the entire product development and/or approval process can be jeopardized.
Added to this is the system level: in medical devices, mechanical, electronic, and software components constantly influence one another. An anomaly is therefore usually not a localized fault, but rather indicates a connection within the overall system … such as a tolerance chain, thermal effects, or an interface that behaves differently than expected under load.
Starting from fundamental, verifiable requirements, we integrate development, risk assessment, simulation, prototyping, and testing technology in such a way that insights are available early on. This is one of the reasons why we work in an interdisciplinary manner. As you know, when mechanics, electronics, and software are closely integrated, there is naturally less friction. When prototypes, laboratories, measuring equipment, and testing technology are also directly available, your development cycles become shorter. Problems can be identified, assessed, and resolved more quickly.
In our view, reliable verification is achieved through appropriate testing at the right time. That is why we ensure clear test criteria, transparent measurement methods, reproducible test environments, and realistic load profiles. Our test benches and measurement procedures are designed to simulate real-world operating and environmental conditions in such a way that weaknesses become apparent quickly and at an early stage.
In everyday language, the terms verification and validation are often used interchangeably. For development, however, it is important to distinguish between them.
As a development service provider, B&W focuses on verification, as it provides systematic proof that the development meets the specified requirements. Validation, on the other hand, aims to demonstrate the product’s benefits in a real-world application context and requires a deep understanding of the specific operating conditions as well as the target market. This context typically lies with the customer, which is why validation is usually performed by them.
However, the two go hand in hand, and each requires its own methods.
Verification concerns safety, yes, but it also concerns deadlines, costs, and predictability.
If we clearly translate requirements into tests early on and actually carry out those tests, the effort required for changes in later project phases decreases. If risks become apparent early on, decisions can be made with greater confidence, and if evidence is gathered in a structured manner, the path to market launch becomes more stable.
“Verification is a development discipline.”
By integrating requirements, risks, test strategy, and system understanding early on, you develop with greater clarity and confidence. That is where we see our contribution! This means structuring technical complexity in such a way that—with interdisciplinary teams, proprietary testing technology, short feedback loops, and a clear view of the overall system—robust products are created.
