Risk Management
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 current revision of ISO-10993 will include a risk based approach. IEC 60601 in the third edition requires a risk management process throughout the whole standard. Still, many companies lack the process to implement this.
We help you with:
- Training
- Development of procedures/processes
- Implementation of the processes
- Software risk management
- Process risk management
- Integrating Risk Management in your quality system
- Integration of Risk Management to IEC-60601, 3rd Edition
- Auditing of your Risk Management process
- Leading Risk Management activities
- Risk analysis methods