Risk Management in Medical Devices Industry

Topics

• The requirements of ISO 14971
• The risk management process, the activities, and deliverables as well as the organization framework necessary
• Risk analysis team meetings
• Developing a risk analysis framework document
• How to apply ISO 14971 into development process
• How and where to use the various techniques during the design life cycle
• How Risk Management system fits into quality system and business practices
• How to document your Risk Management
• Performing risk assessments effectively

Who should Attend

• Risk managers
• Project managers
• Quality Assurance personnel
• Engineering management
• System and design engineers
• Regulatory and Compliance professionals responsible for FDA / notified body interactions
• Usability Engineers
• Software Engineers
• Production Managers
• Verification / validation personnel