7005 Taschereau Boulevard, suite 265, Brossard, QC J4Z 1A7, Canada
+1 (450)-678-8882

Quality

Regulation

Privacy

QUALITY
ISO-13485_2016-black-TM
IISO 13485:2016 Certified

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

Intertek-MDSAP-Certified-3-Black
 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
fda
IFDA

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

logo-health-canada-300
Health Canada

CARA has license from Health Canada (# 81422 ) and is approved for sale in Canada as a Class II Medical Device

CE-marking-logo
 CE marketing

CARA has CE marking and is approved for sale in the EU as a Class I Medical Device

Earth Globe isolated on white Background. World Map. Earth Icon. Clean and modern vector illustration for design, web.
 Other regions

CARA complies with various local regulations. Please contact us to know if CARA is approved for sale in your country

Privacy
HIPAA -- the Health Insurance Portability and Accountability Act, sets the standard for protecting sensitive patient data.
IHIPAA
Diagnos is HIPAA (https://www.hhs.gov/hipaa/index.html) Compliant. For any questions, please contact: info@diagnos.ca