Hot Topics in Risk Management & Medical Devices

Roberta Goode, President & CEO of Goode Compliance International, weighs in on the latest challenges medical device manufacturers are facing in risk management at Medical Device Summit’s HHE, Risk Assessment, & Recalls Conference in Washington, DC. One of the top concerns is how the regulatory bodies in the United States and Europe will interpret and implement the EN ISO 14972:2012, especially as it relates to the three annexes that were released. Goode explains how industry is struggling with some of the requirements, as well as the expectations of the Notified Bodies and how FDA is implementing the standard.