Significant and Nonsignificant Risk Medical Devices

Released on by Prakash Srinivasan Timiri Shanmugam
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  • Significant and Nonsignificant Risk Medical Devices Book Detail

  • Author : Prakash Srinivasan Timiri Shanmugam
  • Release Date : 2024-04-27
  • Publisher : Springer
  • Genre : Technology & Engineering
  • Pages : 0
  • ISBN 13 : 9783031528378
  • File Size : 26,26 MB
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Significant and Nonsignificant Risk Medical Devices by Prakash Srinivasan Timiri Shanmugam PDF Summary

Book Description: 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.

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Clinical Evaluation of Medical Devices

Clinical Evaluation of Medical Devices

File Size : 17,17 MB
Total View : 874 Views
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The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approa