SERVICES →

Medical Devices

Classification and registration of Class II, Class III, Class IV and IVDD medical devices.

SERVICES →

Medical Devices

Classification and registration of Class II, Class III, Class IV and IVDD medical devices.

Strategic guidance and advice at every stage of the regulatory process for your medical device approval.

Whether you are a manufacturer, importer or distributor, selling devices into the Canadian market place can be challenging.  Regulatory requirements are not getting easier to navigate. We have the professionals with real-world experience and tools in place to help make your Canadian, U.S. FDA and international regulatory submissions seamless.

Solutions and Services

  • Regulatory Audit Preparation
  • Quality System Implementation & Maintenance
  • ISO 13485:2016
  • FDA CFR 21 Part 820 – Quality System Regulation
  • MDSAP (Medical Device Single Audit Program)
  • MDEL (Medical Device Establishment Licensing)
  • HEALTH CANADA – Medical Device Licencing
  • FDA 510(K) Submissions

Contact Us






    Latest Posts