Medical Device Risk Management

And Safety Assurance Cases

Webinar – Thursday, August 28, 2014 @ 11:00 am Eastern

The FDA recently reported that class I recalls have increased from an average of 25 per year before 2008 to 50 in 2011 and 57 in 2012 (1). A class I recall is a situation in which there is a reasonable probability that use, or exposure to, a medical device will cause serious adverse health consequences or death. As the complexity and sophistication of medical technology and health care infrastructure continue to increase, assuring proper identification and adequate risk controls of these potential recall situations (i.e. hazardous situations) prior to the device being placed on the market is becoming more and more critical and challenging. How effective are the existing medical device risk management practices in assuring proper identification and controls of risks? Are there any gaps and opportunities? How can these gaps be addressed? What is FDA’s view on this issue?

The webinar will provide an overview of limitations with existing risk management practices and introduce methods through examples how these limitations can be addressed through integrating with assurance cases. The webinar will have speakers from FDA to answer your questions about risk management and safety assurance cases after the session content has been presented.

• Fubin Wu, Co-founder, GessNet™

CLICK HERE  for additional information and registration.