Quality Performance Improvement
This training is designed to provide general structure of Canada Medical Device Regulations (CMDR) to apply to the sale or advertisement for sale of any medical device, as well as the import of any medical device for sale or for use on other individuals.
Canadian Medical Device Regulations (CMDR) was previously CMDCAS. Published in 1998 as part of the Food and Drugs Act, the goal of the CMDR is to ensure that medical devices that are sold or imported in Canada are safe and effective for their intended use. The regulations apply to the sale or advertisement for sale of any medical device, as well as the import of any medical device for sale or for use on other individuals. The CMDR does not cover the import of medical devices for personal use.
By the end of the training, participants would be able to:
- Understand general structure of the Medical Device Regulations of Canada
- Appreciate the applications of these regulations in the medical device industry
- Describe use of MDSAP to demonstrate compliance to CMDR ISO 13485
1 day (9.00am to 5.00pm) or duration proposed at quotation.
Training session includes classroom lecture, exercises, group work and discussion.
Business owner, top management, CEO and Directors who plan / export medical devices to Canadian market, Quality and Regulatory Personnel, Engineers, Managers involved in the design and development, manufacturing and marketing of medical devices for Canadian market.
- Introduction to the Canadian Medical Device Regulations
- Purpose of the CMDR
- Analysis of 5 parts in Canadian Medical Device Regulations
- Guidance Documents of the Therapeutic Products Protectorate (TPP) of Health Canada
- Quality System – MDSAP, CMDCAS, ISO 13485
Certificate of Attendance will be issued to participants who fully participated the training and satisfied the attendance requirements.
Why Engage aNTS / Peplow-Warren?
Peplow-Warren Consultant Team is formed by a group of experienced sector expert, certification auditors, consultants and industry practitioners. They actively involve in international standard and specifications development by acting as active ISO and MOSTI Technical Committee Member. They carry a common mission: they are willing to share their good knowledge with current industry practitioners. Call us today for more detail. We are obliged to work together and grow your business.