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Published by Taylor & Francis Ltd, 2020
ISBN 10: 0367657333 ISBN 13: 9780367657338
Language: English
Seller: THE SAINT BOOKSTORE, Southport, United Kingdom
Paperback / softback. Condition: New. New copy - Usually dispatched within 4 working days. 453.
Condition: New. pp. 184.
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Add to basketCondition: New. 1st ed. 2022 edition NO-PA16APR2015-KAP.
Paperback. Condition: Brand New. 184 pages. 9.25x6.14x0.67 inches. In Stock.
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Add to basketTaschenbuch. Condition: Neu. Druck auf Anfrage Neuware - Printed after ordering - This comprehensive resourceexplains the FDA'sclassification of devices andprovidesexpert guidance ondifferentiatingbetween significant risk and non-significant risk medical device studies.The book isdivided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapterincludesa general introduction and overview of the device, along with guidance onitsworking principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject.Thecoverage alsoincludesreports of prior investigations on the basics of risk determination and the nature of potential harm associated with using individual devices.Significant and Non-Significant Risk Medical Devicesisdesignedto assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development.
Published by Elsevier Science Publishing Co Inc, 2020
ISBN 10: 0128209607 ISBN 13: 9780128209608
Language: English
Seller: Buchpark, Trebbin, Germany
£ 68.10
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Add to basketCondition: Hervorragend. Zustand: Hervorragend | Sprache: Englisch | Produktart: Bücher.
Published by Springer International Publishing, 2023
ISBN 10: 3030918572 ISBN 13: 9783030918576
Language: English
Seller: AHA-BUCH GmbH, Einbeck, Germany
£ 86.60
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Add to basketTaschenbuch. Condition: Neu. Druck auf Anfrage Neuware - Printed after ordering - This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field;Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR;Presents simplified guidelines and regulation points.
Published by Springer International Publishing, Springer International Publishing Apr 2023, 2023
ISBN 10: 3030918572 ISBN 13: 9783030918576
Language: English
Seller: buchversandmimpf2000, Emtmannsberg, BAYE, Germany
£ 86.60
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Add to basketTaschenbuch. Condition: Neu. Neuware -This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing.A critical resource for researchers and professionals in the medical device field;Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR;Presents simplified guidelines and regulation points.Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg 392 pp. Englisch.
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Published by H N H International Limited, 2022
ISBN 10: 1032062525 ISBN 13: 9781032062525
Language: English
Seller: Majestic Books, Hounslow, United Kingdom
Condition: New. pp. 250.
Seller: Ria Christie Collections, Uxbridge, United Kingdom
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Published by Taylor & Francis Ltd, 2022
ISBN 10: 1032062525 ISBN 13: 9781032062525
Language: English
Seller: THE SAINT BOOKSTORE, Southport, United Kingdom
Hardback. Condition: New. New copy - Usually dispatched within 4 working days. 209.
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Published by H N H International Limited, 2022
ISBN 10: 1032062525 ISBN 13: 9781032062525
Language: English
Seller: Books Puddle, New York, NY, U.S.A.
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Seller: California Books, Miami, FL, U.S.A.
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