Introduction to the Canadian Medical Device Regulations for Internal Auditors
An ineffective audit can mean severe consequences, resulting in process failure, customer dissatisfaction and regulatory non-compliance. Optimize your auditing skills with a deeper insight of Canadian Medical Device Regulations and learn what to look for in a quality management system (QMS) that is compliant with ISO 13485.
This course enables a clause by clause understanding of ISO 13485, which outlines the comprehensive requirements of an effective QMS. Develop your understanding of Canadian Medical Device Regulations and what to consider when auditing in conjunction with ISO 13485.
Who should attend?
- Quality Managers
- Internal Auditors
- Regulatory Affairs Managers
Note: Knowledge of the Canadian Medical Device Regulations is a prerequisite for this course
What will I learn?
You will learn about:
- Canadian Medical Device Regulation requirements
- What to consider when auditing the requirements as part of an internal audit in conjunction with ISO 13485
How will I benefit?
This course will help you:
- Prepare, conduct and follow-up on ISO 13485 compliant QMS audit activities
- Gain the skills to assess an organization’s capability to manage its quality management system
- Offer confidence to customers and suppliers that a device meets regulatory requirements
- Write factual audit reports and suggest corrective actions
- Enhance customer satisfaction though effective audit application and commitment to continual improvement
- Training course notes