Introduction to ISO 13485:2016 Medical Devices

This one day course has been designed to provide an insight into the use of ISO 13485:2016 as the basis for a quality management system implemented by medical device manufacturers.

Time will be spent during the course exploring the requirements of ISO 13485:2016 and how the standard interacts with ISO 9001:2015, the European Medical Device Directive and the US FDA’s Quality System Regulation. In addition to this, participants will also gain an awareness of the relationship between ISO 13485:2016 and ISO 14971, Application of Risk Management to Medical Devices.


Who should attend?

  • Senior Management
  • Quality Managers
  • Regulatory Affairs Managers
  • Internal and external Auditors
  • Consultants
  • Anyone involved with the implementation of the standard

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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?

  • 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.

What's included?

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