How to Conduct Medical Device Risk Analysis Effectively 2015

Topics

• Risk analysis process
• FDA requirements
• Qualifications of personnel
• Assessing criticality of risks
• Preliminary Hazard Analysis
• Failure Mode and Effects Analysis
• Hazard Analysis for Critical Control Points
• Fault Tree Analysis
• Documentation requirements
• Paradigms for efficiency and effectiveness
• Risk evaluation
• Risk assessment
• Case histories
• World class best practices

Who should Attend

• All Hardware engineers and managers
• All senior managers
• R&D staff
• Production staff
• Regulatory staff
• Quality Assurance staff
• Servicing staff
• Marketing staff
• Manufacturing Engineering staff
• Product Safety staff