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ART Medical has received FDA clearance for marketing the smARTrack system in the US. Additionally, we have received CE Mark, which certifies that it has met the European Union’s consumer safety, health and environmental requirements for both smART system and smARTrack systems, and received AMAR marketing approval in Israel. We also received ISO 13485:2003 certification, Quality Management System for Medical Device Companies.
ART Medical’s development processes are compliant with international standards, by implementing a thorough Quality Management System involving:
- Continuous improvement processes
- Compliance with applicable standards
- Dynamic and productive work environment
- Rigorous monitoring and control methods