This 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.
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. This course 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 regulations; MDR 2017/745 and IVDR 2017/746
Who should attend?
This course is ideal for you if you’re in QA/Regulatory/Engineering/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's included?
- This is an online, eLearning course.
- You’ll have access to the course for 30 days.
On completion, you'll be awarded an internationally recognized BSI Training Academy certificate.
For information on the process after applying for on-demand training, how to take the training, etc., please refer to Accessing BSI E-learning Courses.
Course Guide
Course Duration Hours
- 4 Hours
Payment
Invoice(Bank Transfer)
We will send you an invoice (PDF) by e-mail within 5 business days after your application. Please make payment by bank transfer by the due date as indicated on the invoice.
Credit Card
We will send you a paid invoice (PDF) by e-mail approximately 5 business days after your application. Discounts other than promotional codes are not eligible for card payment.
Cancellation Policy
In the event of cancellation after registration, a cancellation fee of 100% of the full amount of the course fee will be charged.
