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User Experience Center

Medical Device Testing

Medical device testing is a critical step in the design and validation of any medical device. There are generally two types of medical device testing. In a formative test, the goal is to provide a set of specific design recommendations to improve the safety and overall experience, prior to final development or production. In a summative test, the goal is to validate the safety of a device by measuring use errors associated with a core set of critical tasks using a fully functional prototype or a device that is in production.  

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When to use 

Medical device testing with end-users is a required part of the FDA’s 510k application process. While formative testing is not required by the FDA, it is an extremely valuable step in the design process, ensuring that by the time a medical device is validated through summative testing, there are no surprises. The UXC highly recommends both formative and summative testing for any medical device.  

Medical Device Testing at the UXC

The UXC has experience in all facets of the 510K submission process. The UXC staff are familiar with complex recruit criteria, preparing test protocols, running medical device test sessions with clinicians and patients, root cause analysis, measurement of user errors, and reporting. While the UXC will support the 510k submission process, we will not prepare the application itself. The UXC has two state-of-the-art labs to conduct medical device testing. In addition, the UXC utilizes labs in other cities or using remote technologies (when appropriate).


Bentley UXC Services

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