Summative Evaluation / Validation Testing

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.

Our Services

We create and execute FDA and IEC 62366-1 compliant test plans for summative evaluation. This includes:

  • Planning the summative evaluation study
  • Writing the test scenarios and defining the acceptance criteria
  • Creating a moderation guide and note taking guide 
  • Creating a recruitment screener and recruiting participants
  • Conducting the evaluation in one of our laboratories in Germany or US, or elsewhere in the world
  • Writing a final report according to FDA and IEC 62366-1 standards

Contact Us

We are happy to assist you and coordinate the testing effort depending on the approval location (e.g. the US or Europe).


+1 (301) 244 6335


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