TY  - BOOK
AU  - Timiri Shanmugam,Prakash Srinivasan
AU  - Thangaraju,Pugazhenthan
AU  - Sampath,Thamizharasan
AU  - Jagadeeswaran,Indumathy
ED  - SpringerLink (Online service)
TI  - Significant and Nonsignificant Risk Medical Devices
SN  - 9783031528385
AV  - R856-857 
U1  - 610.28 23
PY  - 2024///
CY  - Cham
PB  - Springer Nature Switzerland, Imprint: Springer
KW  - Biomedical engineering
KW  - Medicine
KW  - Research
KW  - Biology
KW  - Clinical medicine
KW  - Biomedical Engineering and Bioengineering
KW  - Biomedical Research
KW  - Biomedical Devices and Instrumentation
KW  - Medical and Health Technologies
KW  - Clinical Research
N1  - 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
N2  - 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
UR  - http://libcon.rec.uabc.mx:2048/login?url=https://doi.org/10.1007/978-3-031-52838-5
ER  -