Risk Management Using ISO 14971 - QCS International

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Medical Device Risk Assessment Management Using ISO 14971

Having an effective risk management system is now a key concern coming under increasing scrutiny from regulatory bodies.

This practical and interactive one-day course will give you the skills and tools to perform risk assessments and manage product and process risks using ISO 14971:2019.

Course Cost

Early Bird Price £275 + VAT
Two For Bird Price £485 + VAT

Available as In house course

Upcoming Courses

  • The secrets of what your notified body is looking for in a risk management system.
  • How to manage risk and the product lifecycle using ISO 14971:2019.
  • Why a Failure Mode Effect Analysis is not enough to pass an audit.
  • The key links between product design and controlling your processes.
  • Tool box to effectively manage and control risk.

This course is for anyone who wishes to gain a better understanding of Risk Assessment and Risk Management for Medical Devices.

This course will give you a good practical understanding of Risk Management Systems and ISO 14971:2012. This will help you and your organisation to identify gaps in your risk management system as a basis for improvement – helping you to increase your regulatory compliance and system effectiveness. Our experienced trainers will also guide you through ISO 14971:2012 so that you have a good understanding of what your notified body is looking for the next time they audit you.

Learning becomes easier and more effective if you, as a delegate feel involved and participate. We not only lead the training we also encourage thought and analysis by delegates who subsequently gain greater insight and ability.


To speak with one of our training experts, you can call us on...
01236 734447

Early bird discounts are obtained by reserving a place and paying the discounted fee at the time of booking or invoice date. Two for less discounts are available for two or more people from the same organisation attending the same course, making the reservation at the same time and paying the discounted fee by the invoice date. For all discounts no cancellation refunds are available but transfer may be possible with at least 15 days notice.

Why use QCS for training...

• CQI/IRCA Approved Training Partner for all auditor courses
• Ongoing investment in ALL courses
• Interactive Courses... involving you in the learning experience
• Highly trained and qualified industry experts
• Access at highest level in all sectors
• Competitive prices
• 100% guarantee