Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation
Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation
This handbook is the most exhaustive resource ever written about FDA design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for ...
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This handbook is the most exhaustive resource ever written about FDA design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. As an added bonus, web access to downloadable and editable design control documents are included with this purchase. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 30-50 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.
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Add this copy of Design Controls, Risk Management & Process Validation to cart. $140.91, new condition, Sold by Ingram Customer Returns Center rated 5.0 out of 5 stars, ships from NV, USA, published 2017 by Design Controls, Risk Management and Process Validation for Medical....
Edition:
2017, Design Controls, Risk Management and Process Validation for Medical...
Add this copy of Design Controls, Risk Management & Process Validation to cart. $173.18, like new condition, Sold by GreatBookPrices rated 4.0 out of 5 stars, ships from Columbia, MD, UNITED STATES, published 2017 by Design Controls, Risk Management and Process Validation for Medical....
Edition:
2017, Design Controls, Risk Management and Process Validation for Medical...
Publisher:
Design Controls, Risk Management and Process Validation for Medical...
Published:
2017
Language:
English
Alibris ID:
15806946901
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Seller's Description:
Fine. Trade paperback (US). Glued binding. 442 p. In Stock. 100% Money Back Guarantee. Brand New, Perfect Condition, allow 4-14 business days for standard shipping. To Alaska, Hawaii, U.S. protectorate, P.O. box, and APO/FPO addresses allow 4-28 business days for Standard shipping. No expedited shipping. All orders placed with expedited shipping will be cancelled. Over 3, 000, 000 happy customers.
Add this copy of Design Controls, Risk Management & Process Validation to cart. $173.19, good condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Santa Clarita, CA, UNITED STATES, published 2017 by Design Controls, Risk Manageme.
Edition:
2017, Design Controls, Risk Management and Process Validation for Medical...
Add this copy of Design Controls, Risk Management & Process Validation to cart. $209.14, new condition, Sold by GreatBookPrices rated 4.0 out of 5 stars, ships from Columbia, MD, UNITED STATES, published 2017 by Design Controls, Risk Management and Process Validation for Medical....
Edition:
2017, Design Controls, Risk Management and Process Validation for Medical...
Publisher:
Design Controls, Risk Management and Process Validation for Medical...
Published:
2017
Language:
English
Alibris ID:
15777457033
Shipping Options:
Standard Shipping: $4.99
Choose your shipping method in Checkout. Costs may vary based on destination.
Seller's Description:
New. Trade paperback (US). Glued binding. 442 p. In Stock. 100% Money Back Guarantee. Brand New, Perfect Condition, allow 4-14 business days for standard shipping. To Alaska, Hawaii, U.S. protectorate, P.O. box, and APO/FPO addresses allow 4-28 business days for Standard shipping. No expedited shipping. All orders placed with expedited shipping will be cancelled. Over 3, 000, 000 happy customers.
