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Devine Guidance - A compilation of Dr. D's Quality & Regulatory Articles from 2014 (Paperback): Christopher Joseph Devine Devine Guidance - A compilation of Dr. D's Quality & Regulatory Articles from 2014 (Paperback)
Christopher Joseph Devine
R734 Discovery Miles 7 340 Ships in 10 - 15 working days
Devine Guidance for Managing Key Attributes of a FDA-Compliant Quality Management System - 21 CFR, Part 820 Compliance... Devine Guidance for Managing Key Attributes of a FDA-Compliant Quality Management System - 21 CFR, Part 820 Compliance (Paperback)
Christopher Joseph Devine
R589 Discovery Miles 5 890 Ships in 10 - 15 working days
Devine Guidance for Complying with the European In-Vitro Diagnostic Directive (IVDD) - The IVDD 98/79/EC (Paperback):... Devine Guidance for Complying with the European In-Vitro Diagnostic Directive (IVDD) - The IVDD 98/79/EC (Paperback)
Christopher Joseph Devine
R600 Discovery Miles 6 000 Ships in 10 - 15 working days

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

Devine Guidance for Complying with the European Medical Device Directive (MDD) - The MDD 93/42/EEC (Paperback): Christopher... Devine Guidance for Complying with the European Medical Device Directive (MDD) - The MDD 93/42/EEC (Paperback)
Christopher Joseph Devine
R623 Discovery Miles 6 230 Ships in 10 - 15 working days

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.

Devine Guidance for Complying with the FDA'S Quality System Regulation - 21 CFR, Part 820 (Paperback): Christopher Joseph... Devine Guidance for Complying with the FDA'S Quality System Regulation - 21 CFR, Part 820 (Paperback)
Christopher Joseph Devine Phd
R607 Discovery Miles 6 070 Ships in 10 - 15 working days

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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