AI4MedImaging Medical Solutions S.A. holds CE Mark Certification, UKCA Mark and FDA 510K clearance.
EU CE Mark
AI4CMR EC Certiﬁcate # MDR 740464
FDA 510K Clearance
AI4CMR v1.0 FDA 510K # K220624
ISO 13485:2016 Certificate number MD 740465
AI4CMR UKCA Certificate # UKCA 776320
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, UK MDR 2002 and with FDA Quality System Regulations, 21 CFR Part 820. 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.