Medical Devices

A Canadian Medical Device License (MDL) is required for companies selling Class II – IV medical devices in Canada. For manufacturers, importers and distributors selling medical devices into the Canadian market place, navigating regulatory requirements can be challenging. Our professionals bring real-world experience to make your Canadian, U.S. FDA and international medical devices regulatory registration submissions seamless.

Solutions and Services

We provide the following Medical Devices Regulatory Registration 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

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