Significant and Nonsignificant Risk Medical Devices (2024)
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- Synopsis
- 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.
- Copyright:
- 2024
Book Details
- Book Quality:
- Publisher Quality
- ISBN-13:
- 9783031528385
- Related ISBNs:
- 9783031528378
- Publisher:
- Springer Nature Switzerland
- Date of Addition:
- 09/02/24
- Copyrighted By:
- The Editor
- Adult content:
- No
- Language:
- English
- Has Image Descriptions:
- No
- Categories:
- Nonfiction, Science, Technology, Medicine
- Submitted By:
- Bookshare Staff
- Usage Restrictions:
- This is a copyrighted book.
- Edited by:
- Prakash Srinivasan Timiri Shanmugam
- Edited by:
- Pugazhenthan Thangaraju
- Edited by:
- Thamizharasan Sampath
- Edited by:
- Indumathy Jagadeeswaran
Reviews
Other Books
- by Prakash Srinivasan Timiri Shanmugam
- by Pugazhenthan Thangaraju
- by Thamizharasan Sampath
- by Indumathy Jagadeeswaran
- in Nonfiction
- in Science
- in Technology
- in Medicine