ISO 13485:2016 Medical Devices: Clause by Clause

This two day course has been designed to provide an in depth understanding of ISO 13485:2016.

On completion of this training, participants will be able to apply their knowledge to the development of a ISO 13485:2016 compliant quality management system and help maintain on going certification of their organization.


Who should attend?

  • Regulatory, quality, research, design, development, and manufacturing personnel who will be involved in working with ISO 13485 and need to have a greater understanding of the management system.
  • Organizations preparing to put ISO 13485 in place
  • Personnel who have joined an organization who have ISO 13485 and require in depth knowledge
  • Delegates attending the Lead Auditor to ISO 13485 course who do not already have a good knowledge of the standard

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What will I learn?

  • Explain the scope and the structure of the ISO 13485
  • Describe the requirements of ISO 13485
  • Explain how to understand and interpret and apply the requirements of the standard within an organization
  • Develop an understanding of how the requirements of ISO 13485 are established in an organization and maintained
  • Consider the systems that are required to implement an ISO 13485 quality management system 
  • Discuss how to ensure that the requirements of the system are effectively implemented to allow the organizations quality system to be certified and/or maintain certification

How will I benefit?

  • Understand how to apply the requirements of the ISO 13485 within your organization
  • Gain an in depth understanding of the requirements of ISO 13485
  • Learn how to ensure the maintenance of the ISO 13485 quality management system within your organization
  • Be confident supporting the maintenance of regulatory requirements within the organization
  • Help to maintain ISO 13485 certification
  • Get the confidence to develop a ISO 13485 compliant quality management system

What's included?

You will gain:

  • Training course notes
  • Lunch
  • Refreshments