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 and the European MDR/IVDR. The relationship with ISO 14971 ‘Application of Risk Management to Medical Devices’ is also explored during the course.
Please note: The training is in English.
How will I benefit?
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
Who should attend?
Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.
On completion, you will be able to:
- Explain the use of ISO 13485:2016, as the basis for a quality management system for medical device organizations
- Define the overall structure of ISO 13485:2016
- Apply the process approach concept of the standard
- Recognize the key clauses of the ISO 13485:2016 standard
What is included?
- Access to the platform where classes will be held
- Access to the platform where the materials are posted
- On successful completion of the training, participants will receive an internationally recognized certificate
