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The salient purpose of this book is to provide the readers some additional insight into not only entering devices into the US market place but actually keeping them there. Dr. Devine actually loves the US device market place because the FDA regulations are relatively static. Now that doesn't mean the FDA does not adopt and change to an increasingly dynamic medical device environment in the United States. However, it does mean that FDA is careful when implementing changes to regulatory and statutory requirements versus the EU where the directives change just for the sake of change. Another...

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 purpose of Dr. D's first book is to breakdown and analyze the requirements depicted in the 21 CFR, Part 820, also known as the FDA's Quality System Regulation (QSR). The doctor tackles each of the sections of the QSR 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 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...