This practical guidebook is one of the most comprehensive resources published in the often complicated field of medical device regulation and compliance. FDA has made it clear that it intends to be increasingly vigilant in monitoring medical device compliance, so an up-to-date resource is essential. This book addresses medical device labeling, quality system regulation, complaint handling, recalls, tracking and postmarket surveillance.
||Stephen D. Terman and Neil F. O'Flaherty, Editors
|Number of pages:
||May 24, 2010