ISO 14971:2019 Risk Management for Medical Devices: Requirements EN

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.   Course Outcomes   Upon completion of this training, you will be able to:• Define risk management terminology• Explain how risk management relates to the product lifecycle• Outline the stages of the risk management process• Define the key deliverables of the risk management process• Apply risk management principles within your organization• Identify the links between ISO 14971:2019, ISO 13485:2016 and the MDR 2017/745