Making Risk-Benefit Decisions – Preparing for the New FDA Guidance Documents (Medical Device)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Apr 06, 2012 End Date/Time: Apr 06, 2012
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Description

This webinar on risk-benefit decisions in medical device manufacturing provides attendees with an understanding of the two recently released FDA draft guidance documents - “Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review” and “Design Considerations for Pivotal Clinical Investigations for Medical Devices”. It also covers the relationship to regulatory submissions and the risk/benefit analysis important in a Risk Management System.

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This webinar provides the attendees with an understanding of the recently released draft guidance documents - “Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review” and “Design Considerations for Pivotal Clinical Investigations for Medical Devices”. It also covers the relationship to regulatory submissions and the risk/benefit analysis important in a Risk Management System.

Venue

Online Event
2600 E. Bayshore Road
Palo Alto
California
United States
MORE INFO ON THIS VENUE