Making Risk-Benefit Decisions â€“ Preparing for the New FDA Guidance Documents (Medical Device)
Venue: Online Event
|Event Date/Time: Apr 06, 2012||End Date/Time: Apr 06, 2012|
Why Should You Attend:
In the increasing scrutiny of the safety and effectiveness medical devices, you and your company need a firm grasp of developing issues. Your quality and regulatory department needs a clear understanding of this developing field. You should have a strategy to approach these issues and this webinar provides the necessary framework. Your compliance program should be addressing these issues today. If not, your team needs to attend.
Do you understand the FDA's thinking on risk benefit analysis?
If you need to need to update a 510(k), for example, do you know how the FDA might view the submission?
Do you understand the role of overall risk in your ISO 14971 Risk Management System?
Have you integrated you complaint system with the Risk Management File to evaluate your frequency and severity estimates?
Does your system use information to consider risk/benefit based on new information, such as complaints?
This webinar provides the attendees with an understanding of the recently released draft guidance documents - â€œFactors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Reviewâ€ and â€œDesign Considerations for Pivotal Clinical Investigations for Medical Devicesâ€. It also covers the relationship to regulatory submissions and the risk/benefit analysis important in a Risk Management System.