ISBN-13: 9781468137583 / Angielski / Miękka / 2012 / 288 str.
ISBN-13: 9781468137583 / Angielski / Miękka / 2012 / 288 str.
The book dives into the fundamental requirements needed to be understood for device manufacturers to successfully introduce and market medical devices in the European Union (EU). Requirements for device entry into the EU differ significantly from the requirements defined by the US FDA.