ISO 14971 - Risk Management for Medical Devices

Starts:  Wed, Oct 7, 2026 09:00 AM (Melbourne time)
Ends:  Thu, Oct 8, 2026 12:30 PM (Melbourne time)
Associated with  National Space
Medical device manufacturers and sponsors need to understand and comply with the current Risk Management standard requirements of ISO 14971:2019 (Application of Risk Management to Medical Devices).
 
This course will provide you with the knowledge, skills and tools to implement a risk management process in compliance with the ISO 14971:2019 standard as part of your Quality Management System.
 
At the end of this course, you will be able to:
  • Understand the importance of risk management processes
  • Understand the success factors for an effective risk management process and the benefits it delivers
  • Develop risk management strategies for products and processes
  • Understand the application of the risk management process
  • Be able to conduct a risk assessment in accordance with the standard
  • Assess the risk management process within your organisation against the standard
  • Understand the relationship between ISO 14971:2019 and ISO 13485:2016