|
Arazy Group is a Vancouver based medical device consultant, specialized in marketing medical technology in an international market. We are working in this field for over 15 years and utilize verification, validation, and regulation in the diversified portfolio of medical equipment.
· Our Medical Device Registrations process include Argentina – ANMAT approval, EU CE Mark, US FDA Clearance, Brazil ANIVSA Clearance, Russia Gost-R, Canada CMDCAS compliance, Medical device registration in China – SFDA approval, South Korea KDFA registration, and also registration of medical devices in India, Turkey, Australia, Japan, South Africa, Mexico, and Thailand.
· Our QMS (Quality Management System) include 21 CFR 820, FDA QSR, c GMP; CMDCAS –Canadian Conformity; SOP – Clean room procedure; ANMAT GMT QMS System Implementation; ISO 13485 Quality Management System; Brazil GMP (B-Gmp) Modification; and quality system Audits.
The team of Arazy Group comprises of experts from different fields such as scientists, quality assurance managers, clinical researchers, regulatory specialists, and medical experts.
For any query of further information about Medical Device Registrations browse the website.
Contact Us
Arazy Group
350 | 1333 Johnston Street | Pier 32 | Granville Island | Vancouver BC | Canada V6H 3R9
Phone: 1 604.681.6888 PST - Vancouver, Canada
E-Mail us: info@arazygroup.com
Website: http://www.arazygroup.com
|
