Medical Device Risk Management Using ISO 14971 2012

Topics

• FDA requirements for risk analysis as part of design validation
• An overview of ISO 14971 to place the presentation in context
• The GHTF guidance document on risk management principles
• Recognition status of ISO 14971 by the FDA and for the EU MDD and IVDD
• Failure Modes and Effects Analysis (FMEA)
• Developing a Risk Evaluation Matrix for your product
• Hazard Analysis and Critical Control Point (HACCP)
• Fault Tree Analysis (FTA)

Who should Attend

• Design Engineers
• Validation professionals
• Quality Engineers assigned to validation activities
• Project Managers involved in Design and Development
• Managers
• Quality Auditors
• Quality staff assigned to Customer Complaints or CAPA management