Johner Institut
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![[Translate to English:] Kamera-Display bei einer Usability-Studie im Labor](/fileadmin/user_upload/Header_1200x230_Camera_Filming_Usability_Evaluation-opt.jpg)
As part of post-market surveillance, the MDR also requires the “identification of ways to improve the suitability for use” (MDR, Article 83, paragraph 3).
Many manufacturers ignore this requirement: either no data at all is collected in relation to usability or user errors, or the data that is collected, such as direct user feedback, is not further examined or categorized in relation to usability aspects.
As a result, there are no reliable findings as to whether the usability of the UI enables safe and efficient operation in everyday use even after it has been placed on the market.
![[Translate to English:] team evaluiert usability](/fileadmin/user_upload/Side_Photo_520x290_Team_evaluating_Usability_Results.png)
We would like to support you as manufacturer to perform a more efficient usability engineering, but also to proactively perform a PMS which is conform with the MDR.
Together we determine possibilities how to get utilizable information on usability and use errors and how to evaluate them.
We analyze data base entries to find out whether they are usability-relevant and whether they point to use errors.
We instruct users to perceive and identify use errors and use difficulties during use.
We interview users to obtain their experiences during use of the UI.
We observe user during the work and note possible use errors and use difficulties.
We document and analyze the obtained data for you and discuss possible measure for mitigation.
![[Translate to English:] Usability Experte vor Präsentation](/fileadmin/user_upload/Side_Photo_520x290_Expert_Presentation_Happy_Face.png)
Our usability experts will help you choose the optimal PMS test for your products, providing you with the following benefits:
You meet the requirements of the MDR for surveillance after placement on the market and can report the results to the Notified bodies.
You obtain valuable PMS data you can use for the improvement of the UI for risk mitigation.
You offer user-friendly products which are evaluated during actual use in day-to-day work and can capitalize on it as advantage.
You receive feedback directly from the market, allowing you to determine whether your product is accepted and satisfies users in real-life situations.
Please contact us to arrange an initial consultation with no obligation. We will determine your PMS status and discuss further measures.
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+49 7531 94500 20
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We help you create the prerequisites for the rapid approval of your devices with IEC 62366-1 and FDA compliant summative 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 accelerate the development and approval of your devices through our formative evaluations.
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.
We help you prove your marketing claims quickly and credibly and thus boost the marketing of your devices.
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