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.
The book dives into the fundamental requirements needed to be understood for device manufacturers to successfully introduce and market medical devices...
The purpose of Dr. D's third book is to breakdown and analyze the requirements depicted in the 98/79/EC, also known as the European Directive on In Vitro Diagnostic Medical Devices (a.k.a. the IVDD). The doctor plans to tackle each of the Articles and Annexes sequentially and hopes the readers are able to glean some useful information while enjoying the common-sense, objective, and no-nonsense approach to complying with each of the requirements. The IVDD is somewhat of a quirky Directive when compared to its siblings, the AIMDD and the MDD. It is the doctor's hope that this book demystifies...
The purpose of Dr. D's third book is to breakdown and analyze the requirements depicted in the 98/79/EC, also known as the European Directive on In Vi...
