Software Team has UNI EN ISO 9001:2008 and UNI CEI EN ISO 13485:2012 Quality System Certifications. Both certifications qualify Software Team as a skilled and reliable company for medical software design, development, installation and maintenance. These certifications have been the starting point to successfully overcome the technical inspections required to get the authorization to mark SmartLink 2.1 as a CE Class 2a Medical Device.
SmartLink 2.1 Certificate
SmartLink 2.1 has overcome the inspections made by CERMET (notified body company for certifications) and has been marked as CE Class 2a Medical Device.
The whole package has been certified including SmartPager, the alarms paging system component.
Software Team in cooperation with Tetronik has achieved the ESPA-X certification proving the reliability and effectiveness of our software SmartESPA-X for managing and sending alarms notification to the DAKS-Pro V8.0x messaging system and other ESPA-X compliant systems.