ISO 14971:2019 is the definitive standard for risk management for medical devices and IVDs. The standard lays out a comprehensive approach to managing risks in the life sciences. The course will discuss practical approaches to complying with the standard.
Every regulatory body is now laser-focused on ensuring medical devices are safe and effective. The “risk file” is now closely scrutinized multiple times in the clearance process and so organizing the information and providing in a clear manner is critical to ensuring a smooth path.
Participants will learn about setting corporate policy, establishing risk acceptability thresholds, building a risk management team, using the standard and its associated guidance document (TR 24971) to establish hazards and manage risks, considerations for demonstrating risk controls are implemented and effective, a method to approach overall benefit-risk analysis, and managing risk throughout the life of the product.
Why Should You Attend:
The risk file is one of the first things looked at when regulatory bodies conduct reviews for clearance to market. Errors or omissions in your risk file could lead to lengthy delays in the clearance process. The risk file is also closely examined during any postmarket inspection or review and especially when regulatory bodies investigate any adverse events. Responsibility goes straight to top management now and case history shows that falsifying information can lead to stiff penalties and jail time.Every regulatory body is now laser-focused on ensuring medical devices are safe and effective. The “risk file” is now closely scrutinized multiple times in the clearance process and so organizing the information and providing in a clear manner is critical to ensuring a smooth path.
Participants will learn about setting corporate policy, establishing risk acceptability thresholds, building a risk management team, using the standard and its associated guidance document (TR 24971) to establish hazards and manage risks, considerations for demonstrating risk controls are implemented and effective, a method to approach overall benefit-risk analysis, and managing risk throughout the life of the product.
Areas Covered in the Webinar:
- Why compliance to 14971 is as much a good idea as it is required
- How to “think” in terms of risk management
- Corporate policy and responsibility related to risk management
- Considerations for the risk management participants
- Planning & Organizing
- Characterizing
- Conducting a Hazard Analysis
- Considering types of Risk Controls
- Conducting Risk Management
- Verification & Validation of Risk Controls
- Overall Benefit-Risk Analysis
- Production and Post market considerations
Who Will Benefit:
This webinar is intended for management, systems engineers, project managers and engineers of all disciplines who might be involved in risk managementCourse Provider
Don Hurd,
