The How to Conduct Medical Device Risk Analysis Effectively 2015 is a workshop that covers topics such as:
- 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
The How to Conduct Medical Device Risk Analysis Effectively 2015 brings together:
- 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
