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Significant and nonsignificant risk medical devices

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Significant and nonsignificant risk medical devices/ edited by Prakash Srinivasan Timiri Shanmugam ... [et al.].
其他作者:	Shanmugam, Prakash Srinivasan Timiri.
出版者:	Cham :Springer Nature Switzerland : : 2024.,
面頁冊數:	viii, 433 p. :ill. (chiefly col.), digital ; : 24 cm.;
Contained By:	Springer Nature eBook
標題:	Clinical Research. -
電子資源:	https://doi.org/10.1007/978-3-031-52838-5
ISBN:	9783031528385

Significant and nonsignificant risk medical devices
Significant and nonsignificant risk medical devices[electronic resource] /edited by Prakash Srinivasan Timiri Shanmugam ... [et al.]. - Cham :Springer Nature Switzerland :2024. - viii, 433 p. :ill. (chiefly col.), digital ;24 cm.

Chapter 1. INTRODUCTION -- Chapter 2. GENERAL MEDICAL USE -- Chapter 3. ANAESTHESIOLOGY -- Chapter 4. SIGNIFICANT AND NONSIGNIFICANT RISK CARDIOVASCULAR DEVICES -- Chapter 5. Significant Risk Dental Devices -- Chapter 6. Significant Risk Medical Devices- ENT (Ear, Nose & Throat) -- Chapter 7. Advantages and Disadvantages of Gastroenterology and Urology Implants -- Chapter 8. Significant and non-significant risks of General and Plastic Surgery devices -- Chapter 9. General Hospital Devices -- Chapter 10. SIGNIFICANT RISK MEDICAL DEVICES NEUROLOGY -- Chapter 11. OBSTETRICS AND GYNECOLOGY INSTRUMENTS -- Chapter 12. Medical Devices-Ophthalmic Devices -- Chapter 13. ORTHOPEDICS -- Chapter 14. RADIOLOGY -- Chapter 15. Non Significant Risk Medical Devices.

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. An essential resource for researchers and professionals in the medical device field; Thoroughly covers the distinctions between Significant Risk (SR) and Non-Significant Risk (NSR) device studies; Presents simplified guidelines and regulatory points.

ISBN: 9783031528385

Standard No.: 10.1007/978-3-031-52838-5doiSubjects--Topical Terms:

1366605
Clinical Research.

LC Class. No.: R856

Dewey Class. No.: 610.28

Significant and nonsignificant risk medical devices
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520 $a 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. An essential resource for researchers and professionals in the medical device field; Thoroughly covers the distinctions between Significant Risk (SR) and Non-Significant Risk (NSR) device studies; Presents simplified guidelines and regulatory points.
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