Model Number

MDBIOEMD

Export -  Medical and Dental Devices to new Markets

     Medical Devices & Biosciences International (MDBIO) is a regulatory affairs consulting service. We work with medical or dental device companies whose vision is to expand their market share by exporting and importing medical or dental devices to and from international markets. We provide the regulatory compliance and consulting services for those device companies who have North America on their radar. Our Regulatory Affairs Consultant will prepare premarket applications in accordance to the Medical Devices Regulations. We are focused in getting new and existing products on the market in a timely manner.

     We are committed and take pride in the service we provide. Our office is based near Toronto, Ontario, Canada. Our service has gone beyond the borders of Canada and has expanded through North America, Asia, and Europe. We provide Regulatory Affairs Consulting services for the development of international business and regulatory strategies to North America and foreign companies who plan to enter international markets in North America, Asia, Europe, and others. We will also investigate or handle Trade complaints on your behalf.
  
     If you are an importer or distributor of medical or dental devices and would like to sell, advertise, or distribute a device you will have to prepare and submit an establishment application. Health Canada and FDA are North America medical devices regulatory authorities. These agencies regulate the sale of medical and dental devices in North America. For more information refer to the Health Canada and FDA 510K websites. We specialize in helping medical and dental device companies comply with the Medical Devices Regulations to gain access to North America market. Our hands-on experience provides efficient handling of regulatory affairs.

Contact Medical Devices & Biosciences International for premarket approvals and compliance to the Medical Devices Regulations.