04438nam a22005895i 4500 978-3-031-52838-5 DE-He213 20251030112704.0 cr nn 008mamaa 240801s2024 sz | s |||| 0|eng d 9783031528385 978-3-031-52838-5 10.1007/978-3-031-52838-5 doi R856-857 MQW bicssc TEC059000 bisacsh MQW thema Significant and Nonsignificant Risk Medical Devices [electronic resource] / edited by Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Thamizharasan Sampath, Indumathy Jagadeeswaran. 1st ed. 2024. Cham : Springer Nature Switzerland : Imprint: Springer, 2024. VIII, 433 p. 87 illus., 66 illus. in color. online resource. text txt rdacontent computer c rdamedia online resource cr rdacarrier text file PDF rda 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. Biomedical engineering. Medicine Research. 62598 Biology Research. 65629 Clinical medicine Research. 74123 Biomedical Engineering and Bioengineering. Biomedical Research. 65633 Biomedical Devices and Instrumentation. Medical and Health Technologies. Clinical Research. 74124 Timiri Shanmugam, Prakash Srinivasan. editor. (orcid)0000-0001-5927-3503 https://orcid.org/0000-0001-5927-3503 edt http://id.loc.gov/vocabulary/relators/edt 81696 Thangaraju, Pugazhenthan. editor. edt http://id.loc.gov/vocabulary/relators/edt 81697 Sampath, Thamizharasan. editor. edt http://id.loc.gov/vocabulary/relators/edt 81698 Jagadeeswaran, Indumathy. editor. edt http://id.loc.gov/vocabulary/relators/edt 81699 SpringerLink (Online service) Springer Nature eBook Printed edition: 9783031528378 Printed edition: 9783031528392 Printed edition: 9783031528408 https://doi.org/10.1007/978-3-031-52838-5 ZDB-2-ENG ZDB-2-SXE 62126 62126