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News

Dear visitors of our website,

Before all else, we from Use-Lab want to express our sincere gratitude for all healthcare professionals in Germany and worldwide that work tirelessly to ensure their patients' wellbeing! We also want to thank everyone who still participates in our studies to optimize the usability of medical products and, thereby, provide a valuable input for the development of safe, reliable and efficient medical products.

The development of new medical products and in particular new diagnostic procedures and test kits is essential even in times of crisis such as the current COVID-19 crisis. Neither the coronavirus nor the discussion about a possible postponement of the application of the MDR and IVDR regulation (https://ec.europa.eu/growth/sectors/medical-devices_en), which is currently being discussed by the European Commission, justify delaying the approval of urgently needed, innovative medical devices and in-vitro diagnostics.

Usability engineering today is not only an important aspect in the relevant usability standards of the IEC 62366 series and the IEC 60601-1 series, but also in other standards across the board, such as the ISO 11607-1:2019 with its requirements for materials, sterile barrier systems and packaging systems for primary packaging of sterilized medical products or the IEC 82079-1:2019 or the ISO/DIS 20417 with its special requirements regarding information for use of medical products.

In addition to these standards that make special demands on the topic of usability, the MDR also calls for further consideration of usability-related requirements, such as market observation.

Even in times of crisis, we are happy to support you in answering questions relevant to approval and in offering individual and group training on usability topics – all online, of course.

In addition, we remain a reliable partner for your concerns about usability evaluations and user interface design for medical devices and user information. Formative and summative usability tests are still possible in our own facilities in Steinfurt, taking into account the greatest possible hygiene and infection-prevention measures. Alternatively, we can conduct formative studies, e.g. in the form of expert reviews. In individual cases, it may be useful to already start preparing upcoming studies. In particular marketing claims substantiation studies require an extensive preparatory phase.

We are happy to advise you on any questions you may have. You can reach our managing director, Torsten Gruchmann, by phone at +49 2551 962482 or by e-mail This email address is being protected from spambots. You need JavaScript enabled to view it..

Make use of the time and stay healthy and optimistic.