Usability Evaluations

Ongoing Usability Study in the Laboratory

Fast approval, safe devices, delighted users – usability as a success factor

Fast and Safe Approval

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.

Minimal Effort and Costs

Avoid unnecessary reconciliations, wrong turns, redundant work, and efforts to eliminate errors that are noticed too late. This saves you trouble, time, and money.

Access to Global Markets

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.
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Comprehensive Solutions not only for Usability

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.

Top Experts, Friendly and Helpful

Our experts are not only competent but also friendly. They make collaboration relaxed and productive and take on all tasks, even complete project management.

Safe and Successful Medical Devices

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.

Our comprehensive usability services – product testing in accordance with IEC 62366-1 and FDA requirements

Observation of a Usability Study in the Laboratory

Formative Evaluation (Pre-summative Assessment)

Want to optimize your device during develop­ment? Our formative evaluations are based on FDA and IEC 62366-1 standards and ensure your market success.

Summative Evaluation (Human Factors Validation Test)

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! 

International Marketing Claim Studies

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.

Usability Lab Rental and Test Subject Recruitment

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.

Team Evaluates Study Results

Get in touch now to find the best usability strategy for your devices together. 

 

Contact us, we're happy to help!
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+49 7531 94500 20

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Feedback of our Customers

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Thank you very much for your assistance, which has been very helpful to us. We have always felt that we received sound and professional advice.
Ralph Reitmajer, MTS Medical UG
As a young start-up, we were faced with the challenging task of perfor­ming usability evalu­a­tions with US citizens directly in the US. The Johner Institute proved to be an extremely valuable partner, providing us with crucial support in success­fully achieving our objective. The collaboration was characte­rized by a high degree of profes­siona­lism and produc­tivity. We were able to rely on the team's compre­hensive expertise and reliable support at all times.
neotiv GmbH Team
Many thanks for your support. It was a great professional expe­rience for us and we learnt a lot. We will certainly address our next studies and activities to Johner Institute.
Vittorio Iormetti, B Medical Systems S.a r.l.
For us as a start-up, the Johner Institute, with its Auditgarant and always appro­priately selected contact persons, is an essential source of support and guidance for all kinds of topics and inquiries, whether it's setting up the QMS or individual topics such as usability. In the area of usability, for example, we had an open flank. Starting with the basics and moving on to implemen­tation within product develop­ment, we built up internal know-how with the help of Dr. Philipp Schleer, planned our approach, and filled the neces­sary templates with life. Philipp was always available to answer our ques­tions. We really appreciate the fact that the contact persons for the various topics always remain the same at the Johner Institute, so that we can pick up where we left off at any time.
TEDIRO Healthcare Robotics GmbH Team
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Further support for fast and successful product development and approval

Usability File

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.

E-Learning, Seminars, Workshops

Want to gain more knowledge? Our custo­mized e-learning courses, seminars, and workshops in the field of usability are the key.

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