ISO 13485: Quality Management System for Medical Devices


ISO 13485: Quality Management System for Medical Devices is a conference dedicated to an overview into the use of ISO 13485 as the basis for a Quality Management System (QMS) for medical device manufacturers.

ISO 13485: Quality Management System for Medical Devices covers topics such as:

  • Compare the requirements of ISO 13485 and ISO 9001 and update on the ISO 9001:2015 revisions
  • Introduction to ISO 13485
  • How to achieve ISO 13485 accreditation
  • Interpretation of ISO 13485 and what it means in practice
  • Understanding the roles and responsibilities of quality management in ISO 13485
  • Examples of ISO 13485 non-compliance
  • Compare and contrast the requirements between ISO 13485 and FDA’s Quality System Regulation
  • The relationship between ISO 13485 and ISO 14971 ‘Application of Risk Management to Medical Devices’
  • Unannounced Audits – what to expect
  • Update on the next revision ISO 13485: 2015
  • Benefits from implementing a QMS
  • Successful handling of complaints

ISO 13485: Quality Management System for Medical Devices brings together:

  • Quality Assurance Personnel
  • Quality Managers
  • Internal and External Auditors
  • Regulatory Affairs Managers
  • All those who are involved with the implementation
  • Medical Device Designers and Developers

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