ABSTRACT
This book is intended to serve as a reference for professionals
in the medical device industry, in particular those seeking to
learn from practical examples and case studies. Medical devices,
like pharmaceuticals, are highly regulated and the bar is raised
constantly as patients and consumers expect the best-quality
healthcare and safe and effective medical technologies. Obtaining
marketing authorization is the first major hurdle that med techs
need to overcome in their pursuit of commercial success. In today’s
competitive environment a few months delay in time to market can
cost millions of dollars in missed opportunities.
