Nestmedic has obtained MDR medical certification for Pregnabit and Pregnabit Cloud

Nestmedic's proprietary telemedicine solution, i.e. the remote KTG Pregnabit Pro device and the Pregnabit Cloud platform, received the MDR medical device certificate, the company said. This allows you to start distributing the solution in Europe. Nestmedic is the first manufacturer from Poland with such certification and the first in the world to obtain it for mobile CTG, emphasized.

The company informed about the successful completion of the certification audit of Pregnabit Pro and Pregnabit Cloud for compliance with the requirements of the MDR Regulation at the end of last year. Now this process has been officially completed, and thus Nestmedic has become the first Polish manufacturer to boast a certificate of this type. In Europe, only 12 such documents have been awarded so far, the material says.

“Receiving the certificate marks a key milestone for us and honors the hard work of the entire company. This allows us to start selling solutions on the European market. We expect it to reach 1,000 units by the end of 2023, but this is just the beginning. Our ambition is that in the future the Pregnabit Pro system will become a common element of modern perinatal care in Poland and in the world, which will both support doctors in their daily work and build a sense of security in pregnant women "- commented President Jacek Gnich, quoted in the release.

Nestmedic was established in 2014. The company's team has created an innovative product - a teleKTG system for remote control tests and analyzing the results in the last trimester of pregnancy. Nestmedic debuted on NewConnect in 2017.

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