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Event Details


ISO 13485: Quality Management System for Medical Devices

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Who should attend?

Quality managers Quality assurance personnel Regulatory affairs managers Internal and external auditors Medical device designers and developers All those who are involved with the implementation



This seminar has been designed to provide a comprehensive overview into the use of ISO 13485 as the basis for a Quality Management System (QMS) for medical device manufacturers. The course will review the requirements of ISO13485 and will compare to ISO 9001 and the FDA’s Quality System Regulation. In addition delegates will gain an appreciation of the relationship between ISO13485 and ISO 14971 ‘Application of Risk Management to Medical Devices’. The benefits of implementing a Quality Management System will be discussed and key advice on handling complaints will be provided.


  • Gain a comprehensive overview of ISO 13485:2016
  • Brief overview of the EU Medical Devices Regulation (MDR) and in-vitro Medical Devices Regulation (IVDR)
  • Compare the requirements of ISO 13485 and ISO 9001
  • Understand the roles and responsibilities of quality management in ISO13485
  • Transition planning from EN ISO 13485:2012 to EN ISO 13485:2016 what needs to be achieved before February 2019
  • Consider the relationship between ISO 13485 and the MDR
  • Explore the relationship between ISO 13485 and ISO 14971 ‘Application of Risk Management to Medical Devices’
  • Discover the benefits of implementing a Quality Management System
  • Preparation for the Unannounced Audits as now incorporated into the MDR
  • Take away key advice on handling complaints




Leigh White

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