ISO 14971:2019 Risk Management Requirements for Medical Devices Virtual Online Training Course

Course Aim: This one-day intensive course enables greater understanding of the impact that ISO 14971:2019 has on the decision-making process when manufacturing medical devices. It helps medical device professionals understand how ISO 14971:2019 can improve their business and risk management efforts.

Course Description: This course is designed to provide you with an understanding of ISO 14971:2019 and the impact it has on the design, development, manufacturing and lifecycle of medical devices.  It will also provide medical device manufacturers with knowledge of how ISO 14971:2019 links with the ISO 13485:2016 standard and the MDR 2017/745.

Practical activities throughout the day will give you the opportunity to apply your skills, implementing risk management activities so that these can be embedded within the organization on completion of the course.

How will I benefit?

This course will help you to:

  • Identify the key requirements of ISO 14971:2019
  • Interpret and communicate the key requirements and expectations of ISO 14971:2019 to your organization
  • Gain knowledge of how ISO 14971:2019 links to ISO 13485 and the MDR 2017/745
  • Apply the fundamental risk management activities for medical devices within your organization