ISO 14971 is an ISO standard that represents the requirements for a risk management system for medical devices.
Key Topics
- Choosing the right risk management tools
- Exploring the Risk Management tool set
- Meeting Human Factors regulatory requirements
- What tools are used during each phase of design?
- How to develop an FMEA that meets requirements
- How to document standards compliance
Who should Attend
Design Engineers, Product Risk Management, Medical/Clinical Project Team members, Human Factors Engineers, Process Engineers, Project Managers and Quality Engineers.