📄️ Medical Device Certification
Regulatory pathway
📄️ Quality Management System
Our product is currently a Class I medical device CE-marked under MDD (certified in 2020) and is in transition to Class IIb under EU MDR (classified under Rule 11), a process we are conducting with our notified body BSI. We comply with Risk management standards, as well as Quality management systems and Software life cycle processes for medical devices and usability.
📄️ FDA Strategy
Bridge milestone · Series A catalyst