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Significant and Nonsignificant Risk Medical Devices

Häftad, Engelska, 2025

AvPrakash Srinivasan Timiri Shanmugam,Pugazhenthan Thangaraju,Thamizharasan Sampath,Indumathy Jagadeeswaran

1 129 kr

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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.

Produktinformation

  • Utgivningsdatum2025-08-02
  • Mått155 x 235 x 24 mm
  • Vikt668 g
  • FormatHäftad
  • SpråkEngelska
  • Antal sidor433
  • FörlagSpringer International Publishing AG
  • ISBN9783031528408
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