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Manufacturing medical
devices?
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Plan to sell products in Canada?
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Need to comply with Canadian Medical
Devices Regulations?
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Need to comply with
Health Canada regulations?
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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!
