Taschenbuch. Zustand: Neu. Significant and Nonsignificant Risk Medical Devices | Prakash Srinivasan Timiri Shanmugam (u. a.) | Taschenbuch | viii | Englisch | 2025 | Springer | EAN 9783031528408 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.
Taschenbuch. Zustand: 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.
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In den WarenkorbZustand: New.
Verlag: Springer Nature Switzerland, Springer Nature Switzerland Aug 2024, 2024
ISBN 10: 3031528379 ISBN 13: 9783031528378
Sprache: Englisch
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Buch. Zustand: Neu. Neuware -Significant and Non-Significant Risk Medical Devices is designed to assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development.Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg 444 pp. Englisch.
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In den WarenkorbHardcover. Zustand: Brand New. 441 pages. 9.26x6.11x9.21 inches. In Stock.
Verlag: Springer Nature Switzerland, 2024
ISBN 10: 3031528379 ISBN 13: 9783031528378
Sprache: Englisch
Anbieter: AHA-BUCH GmbH, Einbeck, Deutschland
Buch. Zustand: 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.
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In den WarenkorbZustand: New. Über den AutorPrakash Srinivasan Timiri Shanmugam, PhD, is currently a Senior Toxicologist at Avanos Medical, Inc. in Alpharetta, Georgia. He was previously contracted as an SME-Biocompatibility at Baxter International, Inc. in Roun.