Quality
Regulation
Privacy
IISO 13485:2016 Certified
Diagnos’ Quality Management System has been successfully audited under ISO 13485:2016
MDSAP
Diagnos’ Quality Management System has been successfully audited under the Medical Device Single Audit Program (MDSAP) and is compliant with regulations of Canada and US
IFDA
The CARA device has been cleared as a comprehensive software platform intended for importing, processing and storing of color fundus images as well as visualization of original and enhanced image through computerized networks
Health Canada
CARA has license from Health Canada (# 81422 ) and is approved for sale in Canada as a Class II Medical Device
CE marketing
CARA has CE marking and is approved for sale in the EU as a Class I Medical Device
Other regions
CARA complies with various local regulations. Please contact us to know if CARA is approved for sale in your country
