Topics
- Understanding potential harm scenarios
- Review of FDA alarm related recalls
- Key design techniques to maximize response to alarms
- Translating harm scenarios into good design specifications
- Training and labeling requirements
- Verifying alarm effectiveness
- Retrospective validation
Who should Attend
Regulatory Compliance Associates and Managers, R&D engineers and managers, Quality Assurance personnel, Anyone involved in risk analysis, Marketing and Servicing staff.
