We are pleased to announce that we, as a medical software developer, have received the MDR certificate for the manufacture of class IIa and IIb devices.
The new EU Medical Device Regulation (EU 2017/745), abbreviated MDR, took effect at the end of May 2017. The aim of the MDR is to further increase patient safety by strengthening the transparency and traceability of medical devices through a dedicated product number and ensuring a high standard of quality, among other things.
The new regulation further increases the already demanding requirements for notified bodies, manufacturers, clinical data and market surveillance. The quality management system of Mint Medical was adapted to the significantly heightened requirements of the MDR and successfully audited by TÜV Süd Product Services. The certification confirms that mint Lesion™ meets the strict guidelines of the new regulation and will continue to serve our users as a trustworthy and safe medical device.
