Medical Device 2012 - Making Risk-Benefit Decisions ? Preparing for the New FDA Guidance Documents

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decisions in medical device manufacturing provides attendees with an understanding of the two recently released FDA draft guidance documents - “Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review” and “Design Considerations for Pivotal Clinical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”.

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.