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What is CMDCAS?
Since January 1, 2003, Canadian Medical Device Regulations require manufacturers selling class II, III and IV medical devices within Canada to be registered to ISO 13485:2003 by a quality system registrar accredited by the Standards Council of Canada (SCC) and recognized by Health Canada under the CMDCAS program. LRQA is recognized by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) in accordance with the requirements of Q90R0 Policy on CMDCAS.
For Class II, III or IV medical devices to be licensed by Health Canada, their manufacturers' quality management systems are required to be registered to at least ISO 13485:2003 by a CMDCAS recognized registrar.
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Assessment process for ISO 13485:2003 under the Canadian Medical Device Conformity Assessment System (CMDCAS) program NEW!
This information note is provided to give LRQA clients a brief overview of the Canadian regulatory requirements for medical device manufacturers, highlighting some key aspects.
How can certification to the CMDCAS Scheme benefit my organization?
Certification to the quality management system standards like ISO 13485 help create a systematic framework in which organizations drive continual improvement, providing a competitive advantage for your organization because it:
- enables you to work with many organizations where it is a contractual obligation or expectation
- can provide improved performance measurable in key metric areas such as increased efficiencies, reduced costs and increased revenues
- eases the entry of products and services into foreign and domestic markets and reduces technical barriers to trade since many international trade agreements support the use of international standards and the mutual recognition of conformity assessment results
- exposes businesses to the expertise and research of other organizations within the same industry or sector, translating into enhanced designs and new ideas
- provides businesses with tools to manage risk through the safety and efficiency of their own practices and products
- allows demonstration of social and environmental responsibility in business practices, positively impacting public perception and consumer confidence
For further detail about CMDCAS, visit the Standards Council of Canada.
How can we gain certification to the CMDCAS Scheme?
We provide a range of services, including assessment and training courses, to prepare you for certification. Our certificates are truly earned and are a reliable and transparent symbol of management achievement and a commitment to continual improvement.
- Contact one of our business advisors at 281-646-6390.
- Alternatively, complete the inquiry form on this website.
Our assessment process involves these primary stages:
Why Choose LRQA?
At LRQA, we are passionate about what we do, and we understand what's at stake for your business. We work hard to apply our expertise to make your management systems more efficient and effective. This is why we are one of the world's most trusted management system assessment companies providing assurance for your business and in turn, your clients.
- Reputation and Experience – We have issued over 40,200 approvals at more than 48,420 sites to various standards, schemes and specifications. We are recognized and respected worldwide for our own high standards of technical competence, impartiality and independence.
- Assessor Expertise – We use a unique qualification coding system that matches our assessors' industry knowledge and expertise with your business needs enabling them to conduct an effective and robust audit of your system.
- Assessment Methodology – Our assessments focus on the area and issues that are important to your business. We view the process as more than just certification; we view it as a Business Assurance process that helps you assure key stakeholders that you can deliver on the promises and goals you make.
- Assessment Reports – We will provide helpful and insightful overviews in the Executive Summary, tracking of improvements in key areas in the Continual Improvement logs, and advanced views of your long term assessment plan.
- Extensive range of services –We can provide your organization with assessment, certification and verification services to support your organization's future growth and development. In addition, our comprehensive training courses offer the tools you need to prepare, implement, maintain and improve your management system.
- Integrated Assessments – We will work with you to reduce costs through the effective integration of management system assessments.
- Global Capabilities – We have over 2,000 employees offering assessments in over 30 languages. We operate a single system worldwide, which ensures that our certification process is consistent from any of our offices around the world.
LRQA Business Assurance Approach
Our Business Assurance approach to management systems assessment and reporting is unique; it's an approach that enables you to demonstrate how your system is helping to drive your business forward in a measurable and verifiable way. We believe that building trust stretches far beyond the issuing of certificates. It's about us enabling you to deliver on your promises, to be confident in your capabilities and to stand out from the crowd.
Through Business Assurance, we can help you determine whether your management system:
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