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?
- Take the first steps towards ISO 13485:2016 certification
- Understand how you can better meet customer and 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
- Anyone involved with the implementation of the standard
What will I learn?
On completion of this training, participants will be able to:
- Use ISO 13485:2016 as the basis for a QMS for medical device manufacturers
- Understand the relationship between ISO 13485:2016 and European Medical Device Directives
- Use ISO 13485:2016 as the basis of regulatory requirements worldwide.
What is included?
You’ll be awarded an internationally recognized BSI Training Academy certificate.
We are now offering this training as online training course as well.
> More about our online training
