Use-Lab Usability Validation

Summative usability evaluation

For the purpose of a summative product validation, Use-Lab recruits participants, organizes tests in Germany and abroad, and documents the results:

  • Contacting and recruiting of participants
  • Organization, realization and documentation of
    • Summative usability tests in simulated or real user environments
    • User interviews
  • Preparation of standard-compliant test documents

Final review

In the validation phase, we examine for the last time whether the medical device meets the defined requirements and specifications. It must be ensured that all safety-relevant and frequently used functions can be used safely, efficiently and satisfactorily.

As required by IEC 62366:2007, 62366-1:2015 and IEC 60601-1-6, we involve typical users in the validation process.

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