Health Canada is the agency that regulates medical devices in Canada. Health Canada requires manufacturers of Class 2, 3 and 4 medical devices to meet the requirements of ISO 13485:2003. Companies that do not meet the ISO 13485 requirement will not be allowed to sell their devices in Canada.
Kobridge specializes in helping medical device and IVD companies meet the Canadian requirements so they can gain access to this sizeable market. We can help you implement a new ISO 13485:2003 quality system or upgrade from ISO 9001:2000.