Kropp & själ
Significant and Nonsignificant Risk Medical Devices
Prakash Srinivasan Timiri Shanmugam • Pugazhenthan Thangaraju • Thamizharasan Sampath • Indumathy Jagadeeswaran
Inbunden
1919:-
Uppskattad leveranstid 10-16 arbetsdagar
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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.
- Format: Inbunden
- ISBN: 9783031528378
- Språk: Engelska
- Antal sidor: 433
- Utgivningsdatum: 2024-08-02
- Förlag: Springer International Publishing AG