Significant and Nonsignificant Risk Medical Devices
Significant and Nonsignificant Risk Medical Devices
Buch
- Springer Nature Switzerland, 08/2024
- Einband: Gebunden, HC runder Rücken kaschiert
- Sprache: Englisch
- ISBN-13: 9783031528378
- Bestellnummer: 11937098
- Umfang: 444 Seiten
- Auflage: 2024
- Gewicht: 828 g
- Maße: 241 x 160 mm
- Stärke: 30 mm
- Erscheinungstermin: 2.8.2024
Achtung: Artikel ist nicht in deutscher Sprache!
Klappentext
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.