Risk Management Using ISO 14971 - QCS International

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ISO 14971 Medical Device Risk Assessment Management Course

Our ISO 14971 course is delivered by highly qualified experts in an interactive and engaging format. This practical one-day course will give you the skills and tools to perform risk assessments and manage product and process risks using ISO 14971:2019.

ISO 14971 sets out the standard for medical device risk assessments and risk management, helping you to identify hazards and mitigate them.

Having an effective risk management system is now a key concern coming under increasing scrutiny from regulatory bodies. Taking this course will help you to use and improve your risk assessments for medical devices.

You can view our upcoming course dates below, or get in touch to learn more.

Course Cost

Early Bird Price £385 + VAT

Available as In house course

Upcoming Courses

This training course will cover the following topics:

  • The secrets of what your approved body is looking for in a risk management system.
  • How to manage risk and the product lifecycle using ISO 14971:2019.
  • Why Failure Mode Effect Analysis alone 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 works in the medical device industry and wishes to gain a better understanding of ISO 14971, risk assessment, and risk management for medical devices. This includes anyone involved in the design and development, production, or distribution stages, as well as auditors.

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.

Our Approach to Training Courses

We believe that learning becomes easier and more effective if you, as a delegate, feel more involved and participate. As we lead the engaging training experience, we actively encourage thought, analysis, and involvement from participants to ensure you gain greater insight and understanding of ISO 14971.

If you would like further information on this training course, you can speak to our experts by calling

01236 734447

or by using our enquiry form below.

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