ISO 13485:2016 Clause by Clause

This two-day course has been designed to provide an in depth understanding of ISO 13485:2016. Learn about the various clauses of the standard and understand the implications behind medical devices quality management. Allow our medical devices experts to guide you in unravelling the standard, and bring Medical Devices Quality Management to your organization.

On completion of training, participants will be able to apply knowledge of the ISO 13485:2016 to the development an ISO 13485:2016 compliant quality management system and to 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 13485:2016 and need to have a greater understanding of the management system.
  • Organizations preparing to put ISO 13485:2016 in place
  • Personnel who have joined an organization who have ISO 13485:2016 and require more in depth knowledge
  • Delegates attending the Lead Auditor to ISO 13485:2016 course

Learning objectives

  • Explain the scope and the structure of the ISO 13485:2016
  • Describe the requirements of ISO 13485:2016
  • 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 13485:2016 are established in an organization and maintained
  • Consider the systems that are required to implement an ISO 13485:2016 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 maintaining certification

Course Benefits

  • Understand how to apply the requirements of the ISO 13485:2016 within your organization
  • Gain an in depth understanding of the requirements of ISO 13485:2016
  • Learn how to ensure the maintenance of the ISO 13485:2016 quality management system within your organization
  • Be confident supporting the maintenance of regulatory requirements within the organization
  • Help to maintain ISO 13485:2016 certification
  • Get the confidence to develop a ISO 13485:2016 compliant quality management system

Next Steps

  • Implementing ISO 13485:2016 - Our Implementing ISO 13485:2016 two-day course is designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2016 certification
  • Introduction to: CE Marking - Gain an introduction to the Medical Device Directives and understand their background and key features. On completion of this course, you'll be able to make informed decisions on meeting the requirements of medical device directives, identify the steps required to reduce the risks in the regulatory process and bring products to the EU market much quicker
  • Medical Devices Risk Management: ISO 14971 - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.