Both the FDA and IEC 62366-1 require formative and summative usability evaluations. It is recommended to perform formative usability tests iteratively at different points in development with 1-2 participants per iteration, so that a total of 4-10 participants are tested. Conducting this testing early means that the requirements of intended users can be identified early during development and their implementation can be tested in the next iteration. In case of one-time formative testing, depending on the complexity of the user interface, the participation of 5-15 users with mature prototypes is recommended.
We create and execute FDA and IEC 62366-1 compliant test plans for both formative and summative evaluation. This includes:
We conduct formative tests using these methods, among others:
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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