Testing Medical Devices for Efficiency and Efficacy 2014

Topics

• Use Scenarios Resulting in Hazards
• Use-Related Hazards
• Designing reliability tests for design
• Test Protocols
• Designing lifetime and performance durability tests
• Designing reliability tests for production
• FDA guidance for reliability testing on a device
• Calculation of Estimated Lifetimes - For fluids in the products, For mechanical/electrical devices
• Verification and Validation
• Device User Interface testing
• Software/hardware integration testing
• Calculation of Estimated Lifetimes

Who should Attend

• R&D Engineers and Managers
• Design Engineers and Managers
• Regulatory Personnel
• QA Engineers and Managers
• Manufacturing Engineers and Managers