Our commitment to the highest quality standards and compliance with the applicable regulatory requirements set forth by the European Union (EU) is demonstrated by the recent certification of the CloudCare software as a class IIa Medical Software under the new EU Medical Device Regulation (MDR). We upgraded on June 1 from our previous certification Class I under MDD.
Speaking about the significance of this milestone, dr. Henk Veeze, founder of Diabeter said “This is positive news for people living with diabetes across Europe who are insulin dependent. This certification opens the door to more diabetes care teams across the continent to benefit from powerful insights generated by the CloudCare solution about how their patients are managing their condition and offering them personalized care based on individual needs. Our goal is to help improve patient experience and clinical outcomes while driving clinic efficiencies.”
