OPPORTUNITIES AWAIT IN THE GLOBAL MARKET
There is intense pressure to get every sale to make up for the huge investment in R&D and regulatory approvals. New markets are opening up at a constant rate enabling your products to reach those around the world who need them.
Our team of experts can work with you to research and identify a specific path into these markets, unique to your device and then hold your hand during the process.
From product concept to post-market commercialization, we can design solutions to meet your needs.
Even supply chains are becoming more complex globally and we can support your business with 2nd party inspections to your specifications.
August 9, 2016: Medical Device Quality Management Systems: Transition To New Standard
September 12, 2016: Guidance: Class 4 In-House IVDs – Using the Online Application Form
February 24, 2017: Clinical Evidence Guidelines: Medical Devices
April 22, 2016: Guidance Document: Labeling of In Vitro Diagnostic Devices
September 23, 2016: Guidance Document: Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs)
November 3, 2016: Guidance Document: Medical Devices Recall Guide
March 14, 2017: Guidance Document: GD207 – Guidance on the Content of ISO 13485 Quality Management System Certificates Issued by Health Canada Recognized Registrar
January 11, 2016: Circular Letter No. 1: Refurbishment of Medical Device
August 5, 2016: Circular Letter No. 4: Transition Period for Medical Device Labeling
August 8, 2016: Circular Letter No. 3: Change of Ownership for Medical Device Registration
August 8, 2016: Circular Letter No. 5: Imposition of Charges or Fees for Product Classification
July 19, 2016: Circular: New Procedures for Filing of Application for Medical Device Product Registration and Medical Device Establishment License
July 19, 2016: Circular: Dealing with Eye Drops Products and Botox and Hyaluronic Acid Injections
November 1, 2016: Health Products (Medical Devices) (Amendment) Regulations 2016