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Canadian Medical
Device Regulations (MDR) Management
Systems
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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 MDR and ISO
13485?
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Need to improve field action and customer
complaint processes?
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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
Device Regulations (MDR).
A Quality Management System compliant with these regulations is mandatory for a
medical device manufacturers selling their products in
Canada. While Canadian MDR 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
Device 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 ISO management system needs!
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