📄️ Medical Device Certification
We got our first regulatory approval on 2020, while the MDD was in force. Under this regulation, our solution is a Class I medical device. However, under the current MDR, the solution is a Class II.a medical device.
📄️ Quality Management System
As a Class I medical device for diagnostic support, we comply with Risk management standards, as well as Quality management systems and Software life cycle processes for medical devices and usability.