Industry, FDA Coming Together On Risk Management For Marketed Devices
This article was originally published in The Silver Sheet
Executive Summary
Online-Only Content >>> Representatives from the device industry and FDA are trying to establish common ground for how to assess and manage risk of potential safety or compliance issues that crop up for marketed devices.
You may also be interested in...
Apply Risk Analysis Concepts To Quality Data Reviews To Pinpoint Severe Device Problems Faster
Device-maker Steris' director of regulatory affairs explains why it's important for device manufacturers to view quality data through the prism of risk management.
Apply Risk Analysis Concepts To Quality Data Reviews To Pinpoint Severe Device Problems Faster
Online-Only Content >>> Device-maker Steris' director of regulatory affairs explains why it's important for device manufacturers to view quality data through the prism of risk management.
Let's Talk About Risk: FDA Plans Meeting On Postmarket Risk Management
Online-Only Content >>> FDA will hold an interactive workshop on April 21 to discuss the "clinical considerations of risk in the postmarket environment." The meeting will build on a process launched last fall when representatives from industry and FDA met to establish draft principles for managing unanticipated risks for marketed devices.