Canadian Medical Device Regulations (CMDR)
Quality Management System Documentation

• Selling medical devices in Canada?

• Need to establish compliance with regulatory requirements?

• Need to improve effectiveness of your QMS?

• Folks on the floor do not always follow procedures?

• Wish you could do things right the first time?

We can help!  If your company sells medical devices in Canada, the company is required to maintain a  quality management system compliant with the Canadian Medical Device Regulations (MDR).  This system is based on ISO 13485 standard and includes additional specific to Canada requirements.  Quality Works team has developed and offers documentation templates for ISO 13485 Quality Management System (QMS).  Use of templates is a widely used approach to establishing and documenting a quality management system. Quality Works assisted dozens of companies around the World in establishing and implementing effective QMS. Our documentation will save you time and money in documenting your Canadian MDR compliant quality management system.

Feel free to compare our documentation with others: you will find that our products are the most effective, simple and yet addressing all the requirements of Canadian MDR regulation.  Quality Works team designed our documentation to establish compliance with the requirements and improve effectiveness of your documentation system to reduce paperwork.  Our documentation is user-friendly, easy to understand and makes good business sense.  Check our Download page to see samples of our documents. While our ISO 13485 and Canadian MDR quality management system documents are easy to customize and implement, our team is always here to assist you in your project.  Check our Consulting, Training and Auditing pages to learn how our experts can give you a jump-start in developing and implementing your Canadian MDR quality management system. Visit our Product page to order your medical device QMS documents.