Significant and Nonsignificant Risk Medical Devices (eBook)

Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Thamizharasan Sampath, Indumathy Jagadeeswaran (Herausgeber)

eBook Download: PDF

2024 | 1. Auflage
VIII, 433 Seiten
Springer-Verlag
978-3-031-52838-5 (ISBN)

Infos

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.

Produkt-Details

• Erscheint lt. Verlag: 1.8.2024
• Zusatzinfo: VIII, 433 p. 87 illus., 66 illus. in color.
• Sprache: englisch
• Themenwelt: Technik
• Schlagworte: biomedical research • clinical research • Food and Drug Administration (FDA) • IDE 21 CFR 812 • IDE 21 CFR 812.2(b) • Institutional Review Boards (IRB) • Investigational Device Exemptions (IDE) • Medical and Health Technologies • Medical Device Design • medical device industry • medical device standards • Nonsignificant Risk Device (NSR) • Significant Risk Device (SR)
• ISBN-10: 3-031-52838-7 / 3031528387
• ISBN-13: 978-3-031-52838-5 / 9783031528385