In contrast to formative usability tests, summative usability tests take place at the end of development with production-equivalent devices and materials. The goal of summative testing is to provide objective evidence that the user interface can be used safely by the intended users in the intended usage environment. In summative testing, all hazard-related usage scenarios must be tested.
Depending on the risk posed by the product and the complexity of the user interface, the participation of 15-25 users per unique user group is recommended. The FDA always requires at least 15 users to participate per user group. Test participants must be US citizens and testing must be conducted in the US.
We create and execute FDA and IEC 62366-1 compliant test plans for summative evaluation. This includes:
We are happy to assist you and coordinate the testing effort depending on the approval location (e.g. the US or Europe).
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