Introduction to ISO 13485:2016 Medical Devices

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 with ISO 9001:2015, the European Medical Device Directive and the US FDA's Quality System Regulation. The relationship with ISO 14971, Application of Risk Management to Medical Devices is also explored during the course.

Who should attend?

  • Senior Management
  • Quality Managers
  • Regulatory Affairs Managers
  • Internal and external Auditors
  • Consultants
  • Anyone involved with the implementation of the standard
"Our international reach is unrivalled with operations in 147 countries"

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.

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.

What's included?

  • You will gain 8 CPD points on completing the course
  • Training course notes
  • Lunch
  • Refreshments

 


COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. In the event of a classroom-based course being deemed unsafe, your training booking will be automatically transferred to online delivery using our highly-interactive virtual classroom - Connected Learning Live.

If you have any questions regarding your booking, please contact training@bsigroup.com or call +44 345 086 9000.


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Course Guide

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