Regulatory
Clearances
AI4CMR is a SaMD with high standard of quality and is CE-marked accordingly to new European Medical Devices Regulation – MDR 2017/745
EU CE Mark
AI4CMR EC Certificate # MDR740464
Underway of achieving of FDA (510 k) Clearance

ISO 13485:2016 Certificate number MD 740465
Regulatory information
AI4MedImaging Medical Solutions S.A. holds the recognized ISO 13485:2016 certification from prestigious British Standards Institution (BSI). In addition to ISO 13485:2016, the company quality system is established and maintained to comply with European Medical Device Regulation MDR 2017/745. AI4CMR software development process is following the IEC 62304:2006+A1:2016 Medical Device software — Software life cycle processes and associated standards and guidances and EN ISO 14971: 2019 Medical device software risk management standard to capture and mitigate risks.