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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.
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:
Our usability experts will help you choose the optimal PMS test for your products, providing you with the following benefits:
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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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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