ISO 14971:2019 Risk Management for Medical Devices: Requirements Training Course

This one-day intensive 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.

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.

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.

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 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.

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

What's included?

  • Internationally recognized BSI Training Academy certificate
  • You will gain 8 CPD points on completing the course
  • Training course notes
  • Lunch
  • Refreshments

In-house training

If you have a group of people to train and a single location that is practical, an expert tutor can deliver training at your premises. Want to know more?

 

Request an in-house training quote >


COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. We’ve been working with all our venues to ensure that COVID secure measures are in place and a member of our team has visited each venue to personally check things over. Enhanced cleaning procedures have been implemented, food and beverage offers adapted, and meeting room layouts have been modified to enable socially distanced events – with anti-bacterial gel and wipes readily available.

If you have any questions regarding your booking of a classroom-based training course, please contact training@bsigroup.com or call +44 345 086 9000.


Save on your learning journey with the BSI Training Academy*

With BSI training online, you can unlock discounts when booking your learning pathway, helping you shape your next few weeks, months or years of development – whilst saving in the process.

Make the most of your training budget by booking your next 2 or more courses with BSI before 27 November 2020 and you’ll save:

  • 15% off your next course

  • 20% off your second course

  • 25% off your third course

Contact our training team today to find out more and book your place. Call +44 345 086 9000 or email training@bsigroup.com.