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
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- 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.
GET IN TOUCH WITH US
To speak with one of our training experts, you can call us on...
01236 734447
Read what our delegates say:
I found the course very helpful to understanding more about ISO 13485 and how to carry out internal audits. Alistair was very helpful on any questions I had and very good at explaining different areas....
Found this course to be very helpful & it gives you a better understanding on how to audit properly & what you are looking for...
Good course which I can relate to my place of work..
Great experience, great trainer, I enjoyed the course very much and I would use QCS again in the future....
Great course very well presented. Active learning through practical exercises is a great way to deliver the course...
The training was very excellent, well informed and tutor knowledge of auditing was tremendous. It will really help me to conduct future audits....