Devine Guidance for Complying with the European Medical Device Directive (MDD): The MDD 93/42/EEC

ISBN-13: 9781468137583 / Angielski / Miękka / 2012 / 288 str.

Dr Christopher Joseph Devine

Opis

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.