Introduction to ISO 13485:2016
Gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.
This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directives and US FDA’s Quality System Regulation.
Who should attend?
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Anyone involved with the implementation of the ISO 13485:2016 standard
On completion, you should gain the knowledge and skills to:
- Explain the use of ISO 13485:2016 as the basis for a QMS for medical device manufacturers
- Identify the relationship between ISO 13485:2016 and European Medical Device Directives
- Recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide
This course will help you:
- Take the first steps towards ISO 13485:2016 certification
- Understand how you can better meet regulatory requirements leading to increased patient safety
- Find ways to increase efficiency and cost savings through quality management
- Monitor supply chains to achieve continuous improvement
- Develop safe and effective medical devices
- Motivate employees through CPD
What will I gain?
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.