Our usability experts support you in all activities or, if you wish, can completely take over the 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.
We advise and support you in the entire planning of your summative usability evaluation or readability (comprehension) tests to ensure a smooth process.
We select the use scenarios and create meaningful test scenarios with clear acceptance criteria to ensure the effectiveness of your usability and readability tests.
We create guidelines for the moderation of the test sessions and instructions for the systematic recording of observers during the evaluation.
We develop questionnaires to select suitable participants and actively recruit test subjects
with the required characteristics.
We provide modern usability labs in various countries to simulate use environments and ensure that evaluations run smoothly.
We summarize the participant profiles, test procedure, key results, detailed analysis of observed use errors and use difficulties, and risk evaluation so that you fulfill all legal requirements.
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.
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.
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.
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.
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.
Contact us now for professional support with your summative evaluations.
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+49 7531 94500 20
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We help you accelerate the development and approval of your devices through our formative evaluations.
With our usability labs in Germany and the USA, you create all the prerequisites for successful usability studies and usability tests.
We take over the complete recruitment of healthcare professionals for your usability studies – from search to support on the day of the test.
We help you prove your marketing claims quickly and credibly and thus boost the marketing of your devices.
Need a standard-compliant usability file (human factors engineering file) to pass audits and approvals? We have the know-how! Our customized templates and professional support make it possible.
Want to gain more knowledge? Our customized e-learning courses, seminars, and workshops put you on equal footing with experts.
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