Joseph M Devine

Devine Guidance for Complying with the European In-Vitro Diagnostic Directive (IVDD): The IVDD 98/79/EC (Volume 3)

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 a...

Devine Guidance - A compilation of Dr. D's Quality & Regulatory Articles from 2014 (Volume 6)

This book dives primarily into the perils associated with medical device establishments that fail to comply with US FDA regulatory requirements. It dissects the specific regulatory issue and provides recommendations on how device establishments can comply with regulatory requirements. This is unlike...

Devine Guidance for Managing Key Attributes of a FDA-Compliant Quality Management System: 21 CFR, Part 820 Compliance (Volume 5)

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 th...

Devine Guidance for Complying with the FDA'S Quality System Regulation: 21 CFR, Part 820

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 wh...

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

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 European Medical Device Directive (MDD): The MDD 93/42/EEC BY Devine, Christopher Joseph ( Author ) ] { Paperback } 2012

[ Devine Guidance for Complying with the European Medical Device Directive (MDD): The MDD 93/42/EEC BY Devine, Christopher Joseph ( Author ) ] { Paperback } 2012

California Automobile Collision Handbook