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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 often misinterpreted IVDD. For those of you
that are frequent followers of Dr. D's weekly rants, posted in The
Medical Device Summit, you will recognize the often poignant prose
employed by Dr. D. That being said, I really hope you enjoy the
book
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.
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