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.

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.
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