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Besides clinical studies, the development and conformity evaluation of medical devices and in-vitro diagnostics require several tests.
We offer for example the following tests:
Every medical device has to be tested for its usability in the context of the conformity evaluation according to MDR. Special requirements are defined by the standard IEC-62366-1. Additionally, for all IVDs it is required to prove their usability after IEC 62366-1 according to the IVDR.
In usability studies the medical device is used and tested by potential users in different situations under observation and it will be assessed whether the requirements for usability are fulfilled. Based on the technical documentation we can develop test protocols, recruit users and conduct the corresponding usability study including analysis and reporting of the results. We can do both formative and summative evaluations of medical devices and IVDs. Our team is at your disposal regarding additional questions concerning user-friendliness.
The delivery accuracy of insulin pumps according to IEC 60601-2-24 will be tested in-vitro. We are equipped with analytical scales with corresponding software and the necessary apparatus for test setup.
To improve the reader-friendliness of our website, we use the generic masculine. In the context of equal treatment, we would like to point out that the content of our website is aimed at all genders and does not contain any valuation.