Regulatory

Clearances

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

UKCA Mark
AI4CMR UKCA Certificate # UKCA 776320

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, 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.

Quality Policy

AI4MedImaging develops, manufactures, and distributes high-quality Software as Medical Device (SaMD) that are safe and effective, meet all applicable regulations, and satisfy our customers.

AI4MedImaging ensures the effectiveness of the quality management system through a committed and engaged workforce, the establishment of quality objectives focused on meeting customer expectations, operational excellence, robust design & development, and a commitment to continual improvement & development of our people, products, and processes.

This policy ensures that AI4MedImaging maintains the effectiveness of the established quality systems and complies with customer and product requirements. It has been formulated and approved by the executive staff of AI4MedImaging.

The policy is explained and discussed at orientation training given to all existing and new employees.