<< Reliable Consulting in Medical Devices >>
RS Consultant Services has been offering consulting services in medical devices and pharmaceuticals for the last 14 years. The company’s president has over 20 years of experience in the medical industry. RS Consultant Services has experienced associates with expertise in dealing with Health Canada including Therapeutic Products Directorate and Health Products and Food Branch Inspectorate. RS Consultant Services associates include ISO 13485:2003 CMDCAS certified auditors.
Over the past 14 years, our company has been preparing and filing submissions. We have successfully obtained marketing approval for a variety of different devices.
<< Canadian Devices Regulation >>
Canadian Medical Devices Regulations came in effect in 1998. According to the regulations, all medical devices are classified into four separate classes. Class IV being the highest risk class while class I being the lowest risk class. Class I devices are exempt from license while devices classified from class II, III and IV requires pre-market approval. Companies are required to have device and/or establishment license to sell the devices.
