VALIDATION / SUMMATIVE TESTING

Looking for support to conduct your Human Factors Validation (Summative) Usability Testing as part of your FDA submission or EU certification?

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We pride ourselves in the rigorous approach we take to accurately plan, execute and report validation testing results, all in line with AAMI / FDA / IEC / MHRA guidelines.​

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Services include:

• Use-Related Risk Review

• Protocol & Discussion Guide Writing

• Moderating

• Data Capturing

• Analysis 

• Reporting