This Webinar will present the best practices for integrating medical device risk analysis into a quality system. This integrated processes spans new product development, design change, production, and post market surveillance for the lifecycle of the device. Objective evidence produced by the integrated processes can be used to demonstrate risk analysis compliance to 21 CFR 820 and ISO 14971 during an audit.
Regulations require ongoing risk management that spans the medical device lifecycle. To satisfy that requirement, risk analysis must be integrated into new product development, design change, PFMEA, CAPA and post market surveillance systems. Integration creates a closed loop system where post market data is fed back into the product development and manufacturing systems.
This webinar will help you implement a risk analysis system that is integrated into downstream processes for the life cycle of the device. This is essential to delivering safe and effective medical devices, and to demonstrate 21 CFR 820/ISO 14971 compliance.
Why Should You Attend:
Effective risk analysis systems help deliver safe and effective medical devices. The best risk management processes help anticipate risks. For these reasons the FDA has increased their emphasis on risk analysis.Regulations require ongoing risk management that spans the medical device lifecycle. To satisfy that requirement, risk analysis must be integrated into new product development, design change, PFMEA, CAPA and post market surveillance systems. Integration creates a closed loop system where post market data is fed back into the product development and manufacturing systems.
This webinar will help you implement a risk analysis system that is integrated into downstream processes for the life cycle of the device. This is essential to delivering safe and effective medical devices, and to demonstrate 21 CFR 820/ISO 14971 compliance.
Areas Covered in the Webinar:
- Several risk analysis formats
- How to identify “Hazards”
- How to calculate “Probability of Occurrence”
- How to determine level of “Harm”
- How to define the level of “Risk”
- Risk Bases Down Stream Action Requirements
- Highest - Verification and Validation required
- Moderate - Verification required
- Low - Process Documentation Only
- Risk vs. Benefits Analysis
- How to connect hazards to Design Inputs for action & traceability
- How to systematically produce objective evidence
- How to evaluate and document risks associated with design changes, complaints, adverse events, CAPA and manufacturing deviations.
Who Will Benefit:
- Quality managers and staff
- Regulatory and Compliance managers and staff
- Product Development and Sustaining Engineering, managers and staff
- Project managers
- Compliance and Product Development Consultants
- Anyone with Product Development, Risk Management, Regulator or Quality Assurance responsibilities
Course Provider
Russell Pizzuto,
