A new approach to verifying and validating medical device development
The list of features in medical devices is rapidly rising: Even the simplest of medical devices—such as diagnostic and monitoring systems—house more and more system components, which add greater functionality to the device at a low cost. But by adding components, device software becomes complex and burdens compliance testing and premarket certification activities, such as 510(k) submissions mandated by the U.S. Food and Drug Administration (FDA).
However, you can address those issues by using a model-based verification and validation process in your medical device development. First, this process can help you better manage the complexity of the software by abstracting it as a model. Second, the process can help you verify and validate an evolving system by leveraging an executable model earlier in the development process. Last, the early validation and verification of a system can help you reduce the total development time and shorten the FDA submission process, a required step for bringing a device to the U.S. marketplace.
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