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?
This course will help you to:
- 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 or Manufacturing role involved in medical device design, development and manufacturing.
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 the IVDR 2017/746
What is included?
On completion, you will be awarded an internationally recognized BSI Training Academy certificate.
BSI's Medical Devices Regulation (MDR) Qualifications
Medical Devices Regulation (MDR) Qualifications
This course forms part of our MDR Practitioner Qualification. This qualification will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner status by successfully completing courses and exams.
I'm interested, please send me more information about the course.
HRD Corp Claimable Course
This training course is HRD Corp claimable programme.
