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21st century cures : modernizing clinical trials : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session, July 9, 2014
| 21st century cures : modernizing clinical trials : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Thirteenth Congress, second session, July 9, 2014 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Publishing Office, , 2015 |
| Descrizione fisica | 1 online resource (iv, 165 pages) |
| Soggetto topico |
Clinical trials - United States
Drugs - United States - Testing Medical instruments and apparatus - United States - Testing Clinical trials Drugs - Testing Medical instruments and apparatus - Testing |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | 21st century cures |
| Record Nr. | UNINA-9910703523803321 |
| Washington : , : U.S. Government Publishing Office, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Assay migration studies for in vitro diagnostic devices [[electronic resource]]
| Assay migration studies for in vitro diagnostic devices [[electronic resource]] |
| Pubbl/distr/stampa | [Silver Spring, Md.] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety |
| Descrizione fisica | 34 pages : digital, PDF file |
| Soggetto topico |
Microbiological assay
Fertilization in vitro Medical instruments and apparatus - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Draft guidance for industry and FDA staff |
| Record Nr. | UNINA-9910698130403321 |
Better health care with quality medical devices [[electronic resource] ] : FDA on the cutting edge of device technology
| Better health care with quality medical devices [[electronic resource] ] : FDA on the cutting edge of device technology |
| Edizione | [Rev. Feb. 2002.] |
| Pubbl/distr/stampa | Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, , [2002] |
| Descrizione fisica | 1 sheet : digital, PDF file |
| Collana |
Just the facts
Publication |
| Soggetto topico |
Medical instruments and apparatus - Testing
Medical instruments and apparatus industry - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Better health care with quality medical devices |
| Record Nr. | UNINA-9910696180203321 |
| Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, , [2002] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Medical device software verification, validation and compliance / / David A. Vogel
| Medical device software verification, validation and compliance / / David A. Vogel |
| Autore | Vogel David A. |
| Pubbl/distr/stampa | Boston : , : Artech House, , ©2011 |
| Descrizione fisica | 1 online resource (444 p.) |
| Disciplina | 610.285 |
| Soggetto topico |
Medical instruments and apparatus - Testing
Biomedical engineering |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-5231-1739-7
1-59693-423-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Machine generated contents note: pt. I Background -- ch. 1 Evolution of Medical Device Software Validation and the Need for This Book -- Evolution of Validation in the Medical Device Industry -- Building a Language to Discuss Validation -- Terminology is the Foundation -- Correct Versus Consistent Terminology -- Terminology Need Not Be Entertaining -- |
| Record Nr. | UNINA-9910459521203321 |
Vogel David A.
|
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| Boston : , : Artech House, , ©2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Medical device software verification, validation and compliance / / David A. Vogel
| Medical device software verification, validation and compliance / / David A. Vogel |
| Autore | Vogel David A. |
| Pubbl/distr/stampa | Boston : , : Artech House, , ©2011 |
| Descrizione fisica | 1 online resource (444 p.) |
| Disciplina | 610.285 |
| Soggetto topico |
Medical instruments and apparatus - Testing
Biomedical engineering |
| ISBN |
1-5231-1739-7
1-59693-423-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Machine generated contents note: pt. I Background -- ch. 1 Evolution of Medical Device Software Validation and the Need for This Book -- Evolution of Validation in the Medical Device Industry -- Building a Language to Discuss Validation -- Terminology is the Foundation -- Correct Versus Consistent Terminology -- Terminology Need Not Be Entertaining -- |
| Record Nr. | UNINA-9910785317003321 |
|
Vogel David A.
|
||
| Boston : , : Artech House, , ©2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Medical device software verification, validation and compliance / / David A. Vogel
| Medical device software verification, validation and compliance / / David A. Vogel |
| Autore | Vogel David A |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Norwood, MA, : Artech House, 2010 |
| Descrizione fisica | 1 online resource (444 p.) |
| Disciplina | 610.285 |
| Soggetto topico |
Medical instruments and apparatus - Testing
Biomedical engineering |
| ISBN |
1-5231-1739-7
1-59693-423-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Machine generated contents note: pt. I Background -- ch. 1 Evolution of Medical Device Software Validation and the Need for This Book -- Evolution of Validation in the Medical Device Industry -- Building a Language to Discuss Validation -- Terminology is the Foundation -- Correct Versus Consistent Terminology -- Terminology Need Not Be Entertaining -- |
| Record Nr. | UNINA-9910818176403321 |
|
Vogel David A
|
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| Norwood, MA, : Artech House, 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Mejor cuidado de la salud con dispositivos médicos de calidad [[electronic resource] ] : FDA a la cabeza en tecnología de dispositivos médicos
| Mejor cuidado de la salud con dispositivos médicos de calidad [[electronic resource] ] : FDA a la cabeza en tecnología de dispositivos médicos |
| Edizione | [Rev. Feb. 2002.] |
| Pubbl/distr/stampa | Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, , [2002] |
| Descrizione fisica | 1 sheet : digital, PDF file |
| Collana |
Just the facts
Publication |
| Soggetto topico |
Medical instruments and apparatus - Testing
Medical instruments and apparatus industry |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Altri titoli varianti | Mejor cuidado de la salud con dispositivos médicos de calidad |
| Record Nr. | UNINA-9910695438703321 |
| Rockville, MD : , : Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, , [2002] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Modifications to devices subject to premarket approval (PMA) [[electronic resource] ] : the PMA supplement decision-making process
| Modifications to devices subject to premarket approval (PMA) [[electronic resource] ] : the PMA supplement decision-making process |
| Pubbl/distr/stampa | [Silver Spring, Md.] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health |
| Descrizione fisica | 25 pages : digital, PDF file |
| Soggetto topico | Medical instruments and apparatus - Testing |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Modifications to devices subject to premarket approval |
| Record Nr. | UNINA-9910698128003321 |
| [Silver Spring, Md.] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Quick tips, when getting medical tests [[electronic resource]]
| Quick tips, when getting medical tests [[electronic resource]] |
| Pubbl/distr/stampa | [Rockville, MD] : , : AHRQ, , [2002] |
| Descrizione fisica | 2 unnumbered pages : digital, PDF file |
| Collana | AHRQ pub. |
| Soggetto topico |
Medical instruments and apparatus - Testing
Diagnosis - Planning |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910698133903321 |
| [Rockville, MD] : , : AHRQ, , [2002] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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