Medical Device Risk Management Using ISO 14971 2012 is a webinar that covers topics such as:
- 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)
Medical Device Risk Management Using ISO 14971 2012 brings together:
- 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
