Risk Management Using ISO 14971: 2007

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 14971:2007.
• 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.