From Device Recalls To FDA Inspectional Changes, QA/RA Experts Must Leap Hurdles In 2018

Device-makers could be in for a change to how they handle product recalls now that US FDA is reevaluating its processes for market withdrawals. That's according to longtime device industry expert Steve Niedelman, who also points out other hot topics that quality and regulatory professionals need to keep a sharp eye on this year – such as the device center's "Total Product Life Cycle" approach and next moves in its "program alignment" inspection scheme – in this Medtech Insight podcast.