This course is pending release. Please contact us for more information regarding the release date.
This e-Learning course fully covers the ISO 13485:2016 requirements. ISO 13485 specifies requirements for quality management systems in order to achieve regulatory compliance in the medical device sector. Many medical device companies are utilizing ISO 13485 as a platform to build their business management systems because of its value or because third party certification is a specified requirement by customers and/or regulators.
This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.
Who Should Attend
This e-Learning course is designed for Quality Assurance Practitioners, Managers, ISO 13485:2016 Implementation Team Members and Management Representatives.
Recommended Training and/or Experience
A general understanding of quality management systems and a minimum of 3 months of relevant experience is recommended.
- Understand the application of Quality Management Principles in the context of ISO 13485:2016. Relate the quality management system to the organization’s medical devices, and provision of related services.
- Introduction and Welcome Chapter 1 – Introduction to ISO 13485
- Chapter 2 – The ISO 13485 Standard Explained MD Written Exercise 1 (individual)
- Chapter 3 – Overview of ISO 13485:2016 Requirements
- MD Written Exercises 2a, 2b (Audit Scenarios)
- Breakout Exercise 2c (Audit Scenarios)
- MD Written Exercise 3 (individual)