Medical devices regulations, standards and practices /
Guardado en:
| Formato: | Libro electrónico |
|---|---|
| Lenguaje: | Inglés |
| Publicado: |
Cambridge :
Elsevier,
c2015
|
| Colección: | Woodhead Publishing Series in Biomaterials
|
| Materias: | |
| Acceso en línea: | Acceso al texto completo (vía IP UNER) Enlace alternativo (vía IP UNER) |
| Aporte de: | Registro referencial: Solicitar el recurso aquí |
| LEADER | 02057nam a2200385 a 4500 | ||
|---|---|---|---|
| 001 | 00012767 | ||
| 003 | AR-OvUNE | ||
| 005 | 20240408101232.0 | ||
| 006 | a|||||o|||| 00| 0 | ||
| 007 | cr |||aaaaaaaa | ||
| 008 | 210916s2015 us a fo 001 0 eng d | ||
| 020 | |a 9780081002919 | ||
| 040 | |c AR-OvUNE |a AR-OvUNE | ||
| 080 | |a 615.47 |b MED | ||
| 245 | 1 | 0 | |a Medical devices |h [recurso electrónico] : |b regulations, standards and practices / |c Seeram Ramakrishna, Lingling Tian, Charlene Wang, Susan Liao, Wee Eong Teo |
| 260 | |a Cambridge : |b Elsevier, |c c2015 | ||
| 300 | |a recurso en línea (ca.236 p.) : |b fig. col. | ||
| 336 | |a texto (visual) |2 RDA | ||
| 337 | |a electrónico |2 RDA | ||
| 338 | |a recurso en línea |2 RDA type carrier | ||
| 490 | |a Woodhead Publishing Series in Biomaterials | ||
| 505 | |a 1. Introduction -- Part One: Regulations and standards: 2. General regulations of medical devices -- 3.Quality management systems for medical device manufacture -- 4. The process of gaining approval for new medical devices -- Part Two: Meeting regulations and standards: 5 - Risk assessment management for a new medical device. -- 6 Safety testing of a new medical device -- 7. Clinical testing of a new medical device -- Part Three: Practices: 8. Product development overview -- 9. Case study: successful development and approval of a new medical device -- 10. Global harmonization of medical devices -- References -- Index | ||
| 650 | 7 | |a Bioinstrumentación |9 8838 | |
| 653 | |a DISPOSITIVOS MÉDICOS | ||
| 653 | |a MANUFACTURA | ||
| 653 | |a REGULACIÓN | ||
| 700 | |e Ramakrishna, Seeram |9 1 | ||
| 700 | |e Tian, Lingling |9 1 | ||
| 700 | |e Wang, Charlene |9 1 | ||
| 700 | |e Liao, Susan |9 1 | ||
| 700 | |e Teo, Wee Eong |9 1 | ||
| 856 | |u https://doi.org/10.1016/C2014-0-02797-9 |y Acceso al texto completo (vía IP UNER) |z (última consulta: 26/09/2023) | ||
| 856 | |u https://www.sciencedirect.com/book/9780081002896/medical-devices |y Enlace alternativo (vía IP UNER) |z (última consulta: 16/09/2021) | ||
| 942 | |2 udc |h 615.47 |c LIB |6 61547 | ||
| 999 | |c 12767 |d 12767 | ||