Summative Evaluation – Human Factors Validation Test

You must fulfill these legal requirements when it comes to summative evaluations

In contrast to formative evaluations, summative usability tests must be carried out with the final device at the end of development to objectively demonstrate the safe use of the user interface in the intended environment.   

Manufacturers must test all hazard-related use scenarios, whereby the participation of 10-25 users per user group is recommended. The FDA requires at least 15 participants per group, who must be US residents. Therefore, these evalua­tions should take place in the US.  

The MDR, IVDR, IEC 62366-1, and FDA all require legible labeling. In parti­cular, safety information must be perceptible and understandable and support safe use.   

Proof that this applies to the instructions for use (IFU), quick reference guide (QRG), and labeling on the device can be provided in readability (comprehension) tests with the intended users. 

Achieve global approvals for your devices with us as your partner

1. Comprehensive Expertise in Medical Devices, IVD Medical Devices, and Combination Products  
   Our experience and in-depth knowledge ensure that you avoid complaints, minimize time-consuming and costly rework, and easily pass approvals, audits, and reviews.

2. Experienced and Competent Moderators
   The routine application of various interview techniques and evaluation methods guarantee a professional evaluation in a pleasant atmosphere and avoid use errors due to test artifacts.  

3. Modern Usability Labs in Germany and the USA  
   Attractive, well-equipped, and easily accessible usability labs ensure the recruitment of test subjects and create representative use environ­ments for the targeted evaluation of medical and IVD medical devices.  

4. Global Approval without Unnecessary Effort  
   Thanks to our own laboratories and partnerships, devices can be appro­ved worldwide in parallel without unnecessary effort or having to carry out redundant usability tests.

5. Professional Consulting Service and Individual Support
   Our experts provide advice and support for all activities, from planning and implemen­tation to analyzing usability evaluations. Our services are tailored to individual needs, devices, markets, and budgets.