Timiri Shanmugam, Prakash Srinivasan. editor. edt http://id.loc.gov/vocabulary/relators/edt Thangaraju, Pugazhenthan. editor. edt http://id.loc.gov/vocabulary/relators/edt Sampath, Thamizharasan. editor. edt http://id.loc.gov/vocabulary/relators/edt Jagadeeswaran, Indumathy. editor. edt http://id.loc.gov/vocabulary/relators/edt SpringerLink (Online service) text sz 2024 1st ed. 2024. monographic eng

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access VIII, 433 p. 87 illus., 66 illus. in color. online resource. 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. 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. edited by Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Thamizharasan Sampath, Indumathy Jagadeeswaran. Biomedical engineering Medicine Research Biology Research Clinical medicine Research Biomedical Engineering and Bioengineering Biomedical Research Biomedical Devices and Instrumentation Medical and Health Technologies Clinical Research R856-857 9783031528385 https://doi.org/10.1007/978-3-031-52838-5 https://doi.org/10.1007/978-3-031-52838-5 240801 20251030112704.0 978-3-031-52838-5