With us, nothing is left to chance. We have the experience, templates, and team of experts to get your devices through the approval process quickly and safely.
Avoid unnecessary reconciliations, wrong turns, redundant work, and efforts to eliminate errors that are noticed too late. This saves you trouble, time, and money.
We give you quick access to global markets with our usability labs in Germany and the USA and our support at FDA pre-submission meetings.
Usability issues are best solved as a team! In addition to our usability experts, we also have expert teams in the areas of risk management, clinical evaluation, and approval for every product type and market.
Our experts are not only competent but also friendly. They make collaboration relaxed and productive and take on all tasks, even complete project management.
Our state-of-the-art laboratories, precise usability evaluations, and market acceptance studies ensure that your devices are not only safe but also successful on the market.
Want to optimize your device during development? Our formative evaluations are based on FDA and IEC 62366-1 standards and ensure your market success.
Want fast market approval? Our experience and efficient summative evaluations provide quick and valid outputs. Rely on our expertise – we will rock your IEC 62366-1 and FDA-compliant usability evaluations!
Want to boost your devices with empirically proven benefits? Our marketing claim studies are the key. From study planning to subject recruitment – we know what to do.
Need realistic product testing? Our modern usability labs are ready and waiting, with professional test subject recruitment, study management, and all-around support for your team on site.
Would you like to ensure the usability and safety of your product even after it has been launched on the market? Our post-market surveillance services for usability are based on the requirements of the MDR and help you to ensure the long-term conformity and performance of your product.
Get in touch now to find the best usability strategy for your devices together.
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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 in the field of usability are the key.
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.
We analyse and evaluate the usability of your medical devices in everyday use in accordance with MDR after they have been placed on the market.
We help you prove your marketing claims quickly and credibly and thus boost the marketing of your devices.
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