Risk Analysis and Risk Mitigation
The specifications usually miss about 60% requirements. Therefore risk risks are inherent in design, manufacturing, and device use even after so much attention paid to the design control process. You can identify more risks than you know if you use the right process for risk analysis. The next step in design control is to design out risks by designing in the risk mitigation strategies. Understanding how mishaps can happen before they happen and preventing them by design is the key to efficient risk management.
Why should you attend?
Understanding the best practices is a profound knowledge. This webinar is conducted by the international risk management consultant and the author of the text Preventing Medical Device Recalls.
- Introduction to ISO 1491
- Risk analysis techniques
- Risk mitigation strategies
- Developing risk acceptance criteria
- Preliminary Hazard Analysis
- Fault Tree Analysis
- Failure Mode, Effects, and Criticality Analysis
- Hazard Analysis and Critical Control Point process
- Hazard and operability study (HAZOP) process
- Mitigating risks to patients by designing for prognostics
- Innovation methods in risk mitigation
- Role of management in risk monitoring
Who should attend?
- If you want to be efficient, the entire cross functional team should attend. But any of the following can attend:
- Senior management
- Design managers and engineers
- Manufacturing managers and engineers
- Quality Assurance staff
- Regulatory affairs staff
- Service engineering managers and engineers