Management Systems

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Medical Devices Regulations

Documentation systems 
Executive an
d staff CMDR training
MDR Consulting

Internal and supplier audits
ISO 13485 Quality Management Systems
Canadian Medical Devices Regulations

Canadian Medical Devices Regulations

  • Manufacturing medical devices?

  • Plan to sell products in Canada?

  • Need to comply with Canadian Medical Devices Regulations?

  • Need to comply with Health Canada regulations?

  • Wish you could do things right the first time

We can help! Quality Works assisted dozens of companies worldwide to establish and implement effective Quality Management Systems meeting requirements of Canadian Medical DeviceS Regulations (MDR).  A Quality Management System compliant with these regulations is mandatory for medical device manufacturers selling or importing to their products in Canada. While Canadian Medical Devices Regulations requires compliance with ISO 13485 standard, there are additional requirements for product classification, licensing, compliance with regulatory requirements and others. You may download Canadian Medical Devices Regulations from the Department of Justice Canada Website.

Check our Products page to see how our documentation sets can help you in developing your Quality Management System or call us for a free, no obligation consultation. We can help!

Call us today to discuss your specific Canadian Medical Devices Regulation system needs!

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