Significant and Nonsignificant 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 Medica...
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| Övriga upphovsmän: | , , , |
| Materialtyp: | Elektronisk E-bok |
| Språk: | engelska |
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Cham :
Springer Nature Switzerland : Imprint: Springer,
2024.
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| Upplaga: | 1st ed. 2024. |
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| Länkar: | https://doi.org/10.1007/978-3-031-52838-5 |
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| 245 | 1 | 0 | |a Significant and Nonsignificant Risk Medical Devices |h [electronic resource] / |c edited by Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Thamizharasan Sampath, Indumathy Jagadeeswaran. |
| 250 | |a 1st ed. 2024. | ||
| 264 | 1 | |a Cham : |b Springer Nature Switzerland : |b Imprint: Springer, |c 2024. | |
| 300 | |a 1 online resource (VIII, 433 p. 87 illus.). |b 66 illus. in color. | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 341 | 0 | |b Table of contents navigation |2 onix | |
| 341 | 0 | |b Single logical reading order |2 onix | |
| 341 | 0 | |b Short alternative textual descriptions |2 onix | |
| 341 | 0 | |b Use of color is not sole means of conveying information |2 onix | |
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| 505 | 0 | |a 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. | |
| 520 | |a 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. | ||
| 532 | 8 | |a Accessibility summary: This PDF does not fully comply with PDF/UA standards, but does feature limited screen reader support, described non-text content (images, graphs), bookmarks for easy navigation and searchable, selectable text. Users of assistive technologies may experience difficulty navigating or interpreting content in this document. We recognize the importance of accessibility, and we welcome queries about accessibility for any of our products. If you have a question or an access need, please get in touch with us at accessibilitysupport@springernature.com. | |
| 532 | 8 | |a No reading system accessibility options actively disabled | |
| 532 | 8 | |a Publisher contact for further accessibility information: accessibilitysupport@springernature.com | |
| 588 | |a Print version record. | ||
| 650 | 0 | |a Biomedical engineering. | |
| 650 | 0 | |a Medicine |x Research. | |
| 650 | 0 | |a Biology |x Research. | |
| 650 | 0 | |a Clinical medicine |x Research. | |
| 650 | 1 | 4 | |a Biomedical Engineering and Bioengineering. |
| 650 | 2 | 4 | |a Biomedical Research. |
| 650 | 2 | 4 | |a Biomedical Devices and Instrumentation. |
| 650 | 2 | 4 | |a Medical and Health Technologies. |
| 650 | 2 | 4 | |a Clinical Research. |
| 700 | 1 | |a Timiri Shanmugam, Prakash Srinivasan. |e editor. |0 (orcid)0000-0001-5927-3503 |1 https://orcid.org/0000-0001-5927-3503 |4 edt |4 http://id.loc.gov/vocabulary/relators/edt | |
| 700 | 1 | |a Thangaraju, Pugazhenthan. |e editor. |0 (orcid)0000-0002-4090-2004 |1 https://orcid.org/0000-0002-4090-2004 |4 edt |4 http://id.loc.gov/vocabulary/relators/edt | |
| 700 | 1 | |a Sampath, Thamizharasan. |e editor. |4 edt |4 http://id.loc.gov/vocabulary/relators/edt | |
| 700 | 1 | |a Jagadeeswaran, Indumathy. |e editor. |4 edt |4 http://id.loc.gov/vocabulary/relators/edt | |
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| 776 | 0 | 8 | |i Printed edition: |z 9783031528378 |
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