01/09/2026
CE marking a medical device isn't just about whether the measurements are accurate.
Shen AI's Medical SDK is certified as a Class IIa software as a medical device under MDR - covering heart rate, HRV, breathing rate, and blood pressure through a contactless, one-minute face scan. But the certification process touched everything: clinical validation, software performance, cybersecurity, usability, and our quality management system.
Our Chief Quality and Regulatory Officer Anna Szopa breaks down what that actually means in practice ⬇️