ISO 14971:2019 Risk Management for Medical Devices: Requirements

This one-day intensive course helps medical device manufacturers understand the benefits and impact of ISO 14971:2019. It’s ideal for anyone in a quality assurance, regulatory, engineering or manufacturing role. We also recommend a basic knowledge of medical device development, quality assurance and ISO 13485:2016.

Through a mix of practical activities, classroom learning and group discussion, you will learn risk management terminology and the stages of the risk management process. You’ll also be able to identify links between ISO 149721:2019, ISO 13485:2016, MDR 2017/745 and IVDR 2017/746.

Available as in-person training or on-demand eLearning, this ISO 14971:2019 requirements training course is designed to improve risk management efforts across your organization.

How will I benefit?

Understand, interpret and explain key requirements of ISO 14971:2019
In-depth knowledge of how ISO 14971:2019 links to ISO 13485 and the regulations; MDR 2017/745 and IVDR 2017/746
Carry out risk management for medical devices within your organization
Gain an internationally recognized BSI training certificate from your partner in learning

Who should attend?

This course is ideal for you if you’re in a QA/Regulatory/Engineering/Manufacturing role involved in medical device design, development and manufacturing.

Prerequisites

You should have experience with, or basic knowledge of, quality management systems for the medical device industry. We recommend you have a basic awareness of medical device development, quality assurance and ISO 13485:2016

What will I learn?

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, MDR 2017/745 and IVDR 2017/746

Our unique accelerated approach fast-tracks learning, improves knowledge retention and ensures you acquire the skills to apply your knowledge straight away. This course involves practical activities, group discussions and classroom learning to help you develop a deeper understanding of the material and have a greater impact on job performance.