Risk Management Using ISO 14971:2009

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 14971:2007.

You will learn...

• 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 14971:2009.
• 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.
  
   

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

What are the benefits to you?
This course will give you a good practical understanding of Risk Management Systems and ISO 14971:2009. 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 14971:2009 so that you have a good understanding of what your notified body is looking for the next time they audit you.

Hands On - Practical Training…
We have developed our training courses to make them hands on and interactive. Simply put, it is our belief that if we keep you involved in learning, you will learn more and be able to use more back at work.

Peace of mind that your qualification is valid…
As an IRCA approved training organisation, our company and our trainers undergo an intensive inspection and assessment every year with the International Register of Certificated Auditors (IRCA) to give you the peace of mind that the training you receive is always to the highest possible standard.

How to book…
Our course calendar can be viewed below or just go to BOOK NOW if you know the course date you require. Not too sure about which course to book? Just call us on 01236 734447 to discuss your training needs further.