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 14971:2012.
Early Bird Price £275 + VAT
- 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 14971:2012.
- 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.
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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....