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ISO 13485:2003 modifications to meet Canadian regulations

Quality system compliance to the ISO 13485 standard is an expectation in many medical device markets worldwide. However, in Canada, ISO 13485 compliance is not enough. Health Canada specifically requires compliance to additional QMS procedures and regulatory requirements before they will approve your device for sale.

In Canada, manufacturers of medical devices classified as Class II, III and IV must demonstrate compliance with ISO 13485:2003 as well as the Canadian Medical Devices Regulations (CMDR). Certification of your CMDR-compliant quality system by a Health Canada CMDCAS [Canadian Medical Devices Conformity Assessment System] accredited registrar is also required before your device can be sold in Canada. 

Emergo has offices in Vancouver and Toronto, and has supported hundreds of clients to meet regulatory and quality system requirements in order to commercialize their devices in Canada.

Already sell in Europe and have ISO 13485 certification? We can help with Canada ISO 13485 and CMDR compliance

If you have already implemented ISO 13485 to sell in Europe and now want to sell in Canada, we can assist you in upgrading your QMS to meet all CMDR requirements. When undertaking your ISO 13485 QMS upgrade project, we will build upon your existing ISO 13485 QMS, adding specific procedures and documentation necessary to comply with the CMDR. We will also assist you to ensure that your ISO 13485 certification has been issued by a Health CMDCAS accredited registrar. Our Health Canada ISO 13485 QMS upgrade also allows you to fully comply with specific regulatory requirements in other markets worldwide. It is impotrant to note that, by January 2019, Health Canada will require compliance with ISO 13485:2016 and Emergo can assist you with the transition from ISO 13485:2003.

Why choose Emergo for your Canadian ISO 13485 QMS upgrade?

  • Emergo specializes in medical device regulatory compliance.
  • Our offices in Canada have assisted medical device companies worldwide with QMS compliance to ISO 13485 and Health Canada CMDR.
  • An Emergo quality system complies not only with Canadian ISO 13485, but also additional medical device regulatory requirements in many other markets.
  • In addition to 13485 consulting, we can assist with medical device licenses in Canada.
  • In most cases we charge a fixed fee for Canada ISO 13485 upgrades.

Please contact us for more information on implementing ISO 13485 or adding the Canadian Medical Device Regulations to the scope of your existing certification.

Ask us for detailed information about Canada QMS compliance services.

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Listen to our 7 minute podcast interview discussing Canada's specific ISO 13485 compliance requirements:

Interested in learning more about Canada's QMS requirements? Daryl Wisdahl, Managing Director of Emergo Canada, answers some of our most frequently asked questions in this podcast interview.