Registration
Risk management for medical devices
Mar 03, 2011
London, UK
A one day course based on the demands of ISO-14971:2007.
Risk management has developed from a marginal activity, mostly done when the product is ready, to become a central activity throughout the lifecycle of a product. With the implementation of ISO14971:2007 the requirements for risk management have been raised to a new level. Top management responsibilities are detailed and the requirement for documented policy added.
The aim of this course is to develop a fundamental understanding for risk management and how it should be applied in research and production as well as for products on the market.
Key topics
• What is a risk?
• What is the aim with risk management and when is it completed?
• How do you document your risk management process?
• What should you do and when should you do it?
• What tools should you use in your risk analysis?
• How do you use the results from your risk management in your research projects?
• How to apply risk management in production
• How to manage risk management for a product in the field.
• Examples
Mats Petersson from Synergus will be the speaker for this event. Mats have a vast experience of risk management from his consultancy work as well as working in the medical device industry.