We made it! Our current quality management system according to EN ISO 13485 as well as our class IIa medical device, the open-flow microperfusion catheter and all corresponding disposables, successfully achieved the transition to MDR compliance. We thank everybody in our team for their effort, paper-work and patience to achieve this major milestone in regulatory compliance at our institute.
Our current certificates are available here:
EN: https://www.joanneum.at/en/get-to-know-us/get-to-know-us/quality-management
DE: https://www.joanneum.at/lernen-sie-uns-kennen/lernen-sie-uns-kennen/qualitaetsmanagement