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Softcover - 9783031528408
85,59 €
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Beschreibung
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.
Details
| Verlag | Springer International Publishing |
| Ersterscheinung | 02. August 2024 |
| Maße | 23.5 cm x 15.5 cm |
| Gewicht | 828 Gramm |
| Format | Hardcover |
| ISBN-13 | 9783031528378 |
| Seiten | 433 |
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