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A huge milestone: The successful MDR certification

August 4 2023, 9:14

On 27.07.2023, it was a Thursday afternoon, the long-awaited news came from our Notified Body about the successful completion of the MDR certification process. After many invested hours of work, after numerous meetings and after seemingly endless waiting time, we can finally hold our MDR certificate in our hands.

We are overjoyed and very proud to have reached this existentially important milestone under difficult conditions. We now demonstrably meet the requirements of Regulation (EU) 2017/745 on medical devices and can thus from now on not only make our TIVITAproducts even safer and more efficient, but also develop new innovative products and make them available to patients and users on the medical device market.

A big thank you goes to the entire team at Diaspective for all the time and effort that went into this. We would like to explicitly mention the QM/RA team, without whom this successful implementation would not have been possible.

Many, many thanks!