9783031528408 - significant and nonsignificant risk medical devices (8 resultados)

Condición: New.

Taschenbuch. Condición: 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.…

Condición: new. Questo è un articolo print on demand.

Taschenbuch. Condición: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -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. 444 pp. Englisch.…

Condición: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt.

Condición: New. Print on Demand.

Condición: New. PRINT ON DEMAND.

Taschenbuch. Condición: Neu. This item is printed on demand - Print on Demand Titel. Neuware -This comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. The book is divided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapter includes a general introduction and overview of the device, along with guidance on its working principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject. The coverage also includes reports 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 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 KG, Sachsenplatz 4-6, 1201 Wien 444 pp. Englisch.…