Quality
Regulation
Privacy
QUALITY

IISO 13485:2016 Certified
Diagnos’s Quality Management System has been successfully audited under ISO 13485:2016

MDSAP
Diagnos’s Quality Management System has been successfully audited under the Medical Device Single Audit Program (MDSAP) and is compliant with regulations of Canada and US
REGULATION

IFDA
CARA is cleared and approved for sale in the USA as a Class II Medical Device

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
Privacy

IHIPAA
Diagnos is HIPAA (https://www.hhs.gov/hipaa/index.html) Compliant. For any questions, please contact: info@diagnos.ca