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Devine Christopher Joseph (25 results)
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Devine Guidance for Complying with the FDAâS Quality System Regulation: 21 CFR, Part 820
Language: English
Published by CreateSpace Independent Publishing Platform (edition ), 2011
ISBN 10: 1466358769 ISBN 13: 9781466358768
Paperback. Condition: Fair. The item might be beaten up but readable. May contain markings or highlighting, as well as stains, bent corners, or any other major defect, but the text is not obscured in any way.
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Devine Guidance for Complying with the FDA'S Quality System Regulation: 21 CFR, Part 820
Language: English
Published by CreateSpace Independent Publishing Platform, 2011
ISBN 10: 1466358769 ISBN 13: 9781466358768
Seller: World of Books (was SecondSale), Montgomery, IL, U.S.A.
Seller rating 5 out of 5 stars
Condition: Good. Item in good condition. Textbooks may not include supplemental items i.e. CDs, access codes etc.
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Devine Guidance for Complying with the FDA'S Quality System Regulation: 21 CFR, Part 820
Language: English
Published by Createspace Independent Publishing Platform, 2011
ISBN 10: 1466358769 ISBN 13: 9781466358768
Paperback. Condition: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less.
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Devine Guidance for Complying with the European Medical Device Directive (MDD): The MDD 93/42/EEC: Volume 2
Language: English
Published by CreateSpace Independent Publishing Platform, 2012
ISBN 10: 1468137581 ISBN 13: 9781468137583
Seller: WorldofBooks, Goring-By-Sea, WS, United Kingdom
Seller rating 5 out of 5 stars
Paperback. Condition: Very Good. The book has been read, but is in excellent condition. Pages are intact and not marred by notes or highlighting. The spine remains undamaged.
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Devine Guidance for Managing K
Language: English
Published by CreateSpace Independent Publishing Platform, 2014
ISBN 10: 1500209996 ISBN 13: 9781500209995
Seller: World of Books (was SecondSale), Montgomery, IL, U.S.A.
Seller rating 5 out of 5 stars
Condition: Good. Item in good condition. Textbooks may not include supplemental items i.e. CDs, access codes etc.
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Devine Guidance for Managing Key Attributes of a Fda-compliant Quality Management System : 21 Cfr, Part 820 Compliance
Language: English
Published by CreateSpace Independent Publishing Platform, 2014
ISBN 10: 1500209996 ISBN 13: 9781500209995
Condition: As New. Unread book in perfect condition.
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Devine Guidance : A Compilation of Dr. D's Quality & Regulatory Articles from 2014
Language: English
Published by CreateSpace Independent Publishing Platform, 2015
ISBN 10: 1517194393 ISBN 13: 9781517194390
Condition: As New. Unread book in perfect condition.
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Devine Guidance for Managing Key Attributes of a Fda-compliant Quality Management System : 21 Cfr, Part 820 Compliance
Language: English
Published by CreateSpace Independent Publishing Platform, 2014
ISBN 10: 1500209996 ISBN 13: 9781500209995
Seller: GreatBookPricesUK, Woodford Green, United Kingdom
Seller rating 5 out of 5 stars
US$ 30.61
US$ 20.09 shipping
Ships from United Kingdom to U.S.A.Quantity: Over 20 available
Add to basketCondition: As New. Unread book in perfect condition.
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Devine Guidance for Managing Key Attributes of a Fda-compliant Quality Management System : 21 Cfr, Part 820 Compliance
Language: English
Published by CreateSpace Independent Publishing Platform, 2014
ISBN 10: 1500209996 ISBN 13: 9781500209995
Seller: GreatBookPricesUK, Woodford Green, United Kingdom
Seller rating 5 out of 5 stars
US$ 32.46
US$ 20.09 shipping
Ships from United Kingdom to U.S.A.Quantity: Over 20 available
Add to basketCondition: New.
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Devine Guidance for Managing Key Attributes of a Fda-compliant Quality Management System : 21 Cfr, Part 820 Compliance
Language: English
Published by CreateSpace Independent Publishing Platform, 2014
ISBN 10: 1500209996 ISBN 13: 9781500209995
Condition: New.
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Devine Guidance : A Compilation of Dr. D's Quality & Regulatory Articles from 2014
Language: English
Published by CreateSpace Independent Publishing Platform, 2015
ISBN 10: 1517194393 ISBN 13: 9781517194390
Seller: GreatBookPricesUK, Woodford Green, United Kingdom
Seller rating 5 out of 5 stars
US$ 36.23
US$ 20.09 shipping
Ships from United Kingdom to U.S.A.Quantity: Over 20 available
Add to basketCondition: As New. Unread book in perfect condition.
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Devine Guidance : A Compilation of Dr. D's Quality & Regulatory Articles from 2014
Language: English
Published by CreateSpace Independent Publishing Platform, 2015
ISBN 10: 1517194393 ISBN 13: 9781517194390
Seller: GreatBookPricesUK, Woodford Green, United Kingdom
Seller rating 5 out of 5 stars
US$ 42.73
US$ 20.09 shipping
Ships from United Kingdom to U.S.A.Quantity: Over 20 available
Add to basketCondition: New.
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Condition: New.
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Devine Guidance : A Compilation of Dr. D's Quality & Regulatory Articles from 2014
Language: English
Published by CreateSpace Independent Publishing Platform, 2015
ISBN 10: 1517194393 ISBN 13: 9781517194390
Condition: New.
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Liberalism at the Crossroads: An Introduction to Contemporary Liberal Political Theory and Its Critics
Language: English
Published by Rowman & Littlefield Publishers, 2003
ISBN 10: 0742532712 ISBN 13: 9780742532717
paperback. Condition: New. In shrink wrap. Looks like an interesting title!
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Devine Guidance for Managing Key Attributes of a FDA-Compliant Quality Management System: 21 CFR, Part 820 Compliance
Language: English
Published by Createspace Independent Publishing Platform, 2014
ISBN 10: 1500209996 ISBN 13: 9781500209995
Seller: THE SAINT BOOKSTORE, Southport, United Kingdom
Seller rating 5 out of 5 stars
US$ 32.00
US$ 21.44 shipping
Ships from United Kingdom to U.S.A.Quantity: Over 20 available
Add to basketPaperback / softback. Condition: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days.
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Devine Guidance for Complying with the FDA'S Quality System Regulation: 21 CFR, Part 820
Language: English
Published by Createspace Independent Publishing Platform, 2011
ISBN 10: 1466358769 ISBN 13: 9781466358768
Seller: THE SAINT BOOKSTORE, Southport, United Kingdom
Seller rating 5 out of 5 stars
US$ 31.36
US$ 22.87 shipping
Ships from United Kingdom to U.S.A.Quantity: Over 20 available
Add to basketPaperback / softback. Condition: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days.
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Devine Guidance for Complying with the European In-Vitro Diagnostic Directive (IVDD): The IVDD 98/79/EC
Language: English
Published by Createspace Independent Publishing Platform, 2012
ISBN 10: 1478364955 ISBN 13: 9781478364955
Seller: THE SAINT BOOKSTORE, Southport, United Kingdom
Seller rating 5 out of 5 stars
US$ 32.36
US$ 22.51 shipping
Ships from United Kingdom to U.S.A.Quantity: Over 20 available
Add to basketPaperback / softback. Condition: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days.
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Devine Guidance for Complying with the European Medical Device Directive (MDD): The MDD 93/42/EEC
Language: English
Published by Createspace Independent Publishing Platform, 2012
ISBN 10: 1468137581 ISBN 13: 9781468137583
Seller: THE SAINT BOOKSTORE, Southport, United Kingdom
Seller rating 5 out of 5 stars
US$ 34.48
US$ 23.78 shipping
Ships from United Kingdom to U.S.A.Quantity: Over 20 available
Add to basketPaperback. Condition: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days.
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Devine Guidance for Complying with the FDA'S Quality System Regulation (Paperback)
Language: English
Published by Createspace Independent Publishing Platform, 2011
ISBN 10: 1466358769 ISBN 13: 9781466358768
US$ 36.53
US$ 49.54 shipping
Ships from United Kingdom to U.S.A.Quantity: 1 available
Add to basketPaperback. Condition: new. Paperback. 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. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.
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Devine Guidance for Managing Key Attributes of a FDA-Compliant Quality Management System (Paperback)
Language: English
Published by Createspace Independent Publishing Platform, 2014
ISBN 10: 1500209996 ISBN 13: 9781500209995
US$ 36.53
US$ 49.54 shipping
Ships from United Kingdom to U.S.A.Quantity: 1 available
Add to basketPaperback. Condition: new. Paperback. 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 point the author is compelled to make is that once devices are cleared and or approved (depending on regulatory pathway), they will remain available on the US market, providing they remain safe and effective; however, in Europe not so much. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.
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Devine Guidance for Complying with the European In-Vitro Diagnostic Directive (IVDD) (Paperback)
Language: English
Published by Createspace Independent Publishing Platform, 2012
ISBN 10: 1478364955 ISBN 13: 9781478364955
US$ 36.53
US$ 49.54 shipping
Ships from United Kingdom to U.S.A.Quantity: 1 available
Add to basketPaperback. Condition: new. Paperback. 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! This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.
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Devine Guidance for Complying with the European Medical Device Directive (MDD) (Paperback)
Language: English
Published by Createspace Independent Publishing Platform, 2012
ISBN 10: 1468137581 ISBN 13: 9781468137583
US$ 37.23
US$ 49.54 shipping
Ships from United Kingdom to U.S.A.Quantity: 1 available
Add to basketPaperback. Condition: new. Paperback. 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. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.
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Devine Guidance - A compilation of Dr. D's Quality & Regulatory Articles from 2014 (Paperback)
Language: English
Published by Createspace Independent Publishing Platform, 2015
ISBN 10: 1517194393 ISBN 13: 9781517194390
US$ 42.74
US$ 49.54 shipping
Ships from United Kingdom to U.S.A.Quantity: 1 available
Add to basketPaperback. Condition: new. Paperback. 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 most regulatory books written as Dr. Devine tells the story with an edge and some humor. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.
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Devine Guidance - A compilation of Dr. D's Quality & Regulatory Articles from 2014
Language: English
Published by Createspace Independent Publishing Platform, 2015
ISBN 10: 1517194393 ISBN 13: 9781517194390
Seller: THE SAINT BOOKSTORE, Southport, United Kingdom
Seller rating 5 out of 5 stars
US$ 131.20
US$ 17.73 shipping
Ships from United Kingdom to U.S.A.Quantity: Over 20 available
Add to basketPaperback / softback. Condition: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days.
