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.
Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.
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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
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
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?
- 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
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.
Practical information
- It's a 1-day training course
- The training and the materials will be provided in English
- Detailed course notes are provided
- Lunch and drinks are included for the classroom training
For further information regarding reduced rates at the hotel where the training is being conducted, please contact training.nl@bsigroup.com or call +31 (0)20 346 0780.
