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Development of FDA-regulated medical products : a translational approach / / Elaine Whitmore
| Development of FDA-regulated medical products : a translational approach / / Elaine Whitmore |
| Autore | Whitmore Elaine |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2012 |
| Descrizione fisica | 1 online resource (255 p.) |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drug approval - United States
Biological products - Standards - United States Medical instruments and apparatus - Standards - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN | 600-00-4935-8 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910453004303321 |
Whitmore Elaine
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| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of FDA-regulated medical products : a translational approach / / Elaine Whitmore
| Development of FDA-regulated medical products : a translational approach / / Elaine Whitmore |
| Autore | Whitmore Elaine |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2012 |
| Descrizione fisica | 1 online resource (255 p.) |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drug approval - United States
Biological products - Standards - United States Medical instruments and apparatus - Standards - United States |
| ISBN |
0-87389-220-8
0-87389-221-6 600-00-4935-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910779717203321 |
|
Whitmore Elaine
|
||
| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of FDA-regulated medical products : a translational approach / / Elaine Whitmore
| Development of FDA-regulated medical products : a translational approach / / Elaine Whitmore |
| Autore | Whitmore Elaine |
| Edizione | [Second edition.] |
| Pubbl/distr/stampa | Milwaukee, Wisconsin : , : ASQ Quality Press, , 2012 |
| Descrizione fisica | 1 online resource (255 p.) |
| Disciplina | 615.1/9 |
| Soggetto topico |
Drug approval - United States
Biological products - Standards - United States Medical instruments and apparatus - Standards - United States |
| ISBN |
0-87389-220-8
0-87389-221-6 600-00-4935-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910818344903321 |
|
Whitmore Elaine
|
||
| Milwaukee, Wisconsin : , : ASQ Quality Press, , 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Food and Drug enforcement standards for medical devices : joint hearing before the Subcommittee on Human Resources and Intergovernmental Relations and the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fourth Congress, first session, September 14, 1995
| Food and Drug enforcement standards for medical devices : joint hearing before the Subcommittee on Human Resources and Intergovernmental Relations and the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fourth Congress, first session, September 14, 1995 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 1997 |
| Descrizione fisica | 1 online resource (v, 231 pages) : illustrations |
| Soggetto topico |
Medical instruments and apparatus - Safety regulations - United States
Medical instruments and apparatus - Standards - United States Administrative procedure - United States Administrative procedure Medical instruments and apparatus - Safety regulations Medical instruments and apparatus - Standards |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Food and Drug enforcement standards for medical devices |
| Record Nr. | UNINA-9910706247203321 |
| Washington : , : U.S. Government Printing Office, , 1997 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
High-confidence medical devices [[electronic resource] ] : cyber-physical systems for 21st century health care : a research and development needs report / / prepared by the High Confidence Software and Systems Coordinating Group of the Networking and Information Technology Research and Development Program
| High-confidence medical devices [[electronic resource] ] : cyber-physical systems for 21st century health care : a research and development needs report / / prepared by the High Confidence Software and Systems Coordinating Group of the Networking and Information Technology Research and Development Program |
| Pubbl/distr/stampa | Arlington, Va. : , : U.S. Networking and Information Technology Research and Development Program, National Coordination Office, , [2009] |
| Descrizione fisica | 1 online resource (88 pages) |
| Soggetto topico |
Medical instruments and apparatus - Standards - United States
Reliability (Engineering) - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | High-confidence medical devices |
| Record Nr. | UNINA-9910699047603321 |
| Arlington, Va. : , : U.S. Networking and Information Technology Research and Development Program, National Coordination Office, , [2009] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Medical device epidemiology and surveillance [[electronic resource] /] / editors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris
| Medical device epidemiology and surveillance [[electronic resource] /] / editors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris |
| Pubbl/distr/stampa | Chichester, West Sussex, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007 |
| Descrizione fisica | 1 online resource (529 p.) |
| Disciplina | 610.28 |
| Altri autori (Persone) |
BrownS. Lori
BrightRoselie A TavrisDale R |
| Soggetto topico |
Medical instruments and apparatus - Standards - United States
Medical instruments and apparatus - Safety measures - United States |
| ISBN |
1-280-95629-1
9786610956296 0-470-06087-5 0-470-06086-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Medical Device Epidemiology and Surveillance; Contents; Foreword; Preface; Contributors; Acknowledgments; 1 Introduction; 2 Medical device regulation in the USA; Introduction; Premarket review; Marketing applications; Postmarket oversight; Conclusion; 3 Medical device epidemiology; Introduction; Features of medical devices that are relevant to epidemiology study design; Study designs for medical device epidemiology; Summary and recommendations; 4 Surveillance of adverse medical device events; Introduction; Rationale for surveillance; Surveillance based on adverse event reports
Surveillance based on registriesActive surveillance; Necessary conditions for effective surveillance; Ideal AMDE surveillance program; Summary; 5 The Medical Product Surveillance Network (MedSun); Historical motivation; Initial considerations for the design of DeviceNet; MedSun basic design; Current status; Is MedSun successful in promoting the safe use of medical devices?; Epidemiologic considerations; Summary; 6 The National Electronic Injury Surveillance System (NEISS) and medical devices; Description and history of NEISS; Potential uses and limitations of NEISS Utilization of NEISS to produce national medical device-associated adverse event estimatesPotential for long-term utilization of NEISS for medical device surveillance; 7 Medical device nomenclature; Technical elements; Current terminologies; Applications of nomenclature; Future developments; 8 Data sources for medical device epidemiology studies and data mining; Introduction; Data sources; Surveillance databases; Registries; Automated large administrative databases; National surveys; Data mining; Future use databases for medical device epidemiology 9 Ethical requirements and guidelines for epidemiological studiesof medical devicesIntroduction; Bioethics foundations; US government human subjects protection regulations; HHS human subjects protection regulatory requirements; FDA human subjects protection regulations; Other professional ethical guidelines; Ethical requirements for medical devices epidemiologic studies; Future ethical requirements for epidemiologic studies; 10 An industry perspective: medical device epidemiology and surveillance; Introduction The product's life cycle: premarket (preclinical and clinical) and postmarket (PM) studiesPostmarket studies; Summary; 11 Perspective from an academic on postmarket surveillance; Introduction; Adverse event reporting; Postmarket condition of approval studies and Section 522 studies; Industry use of information from adverse event reports; Academic opportunities; Summary; 12 Perspective from a pharmacoepidemiologist; Introduction; Review of literature; Contrasts with pharmacopeidemiology; Conclusions; 13 Medical device regulation and surveillance: perspective from the EU; Introduction Medical devices: the European directives and definitions |
| Record Nr. | UNINA-9910143716903321 |
| Chichester, West Sussex, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Medical device epidemiology and surveillance [[electronic resource] /] / editors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris
| Medical device epidemiology and surveillance [[electronic resource] /] / editors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris |
| Pubbl/distr/stampa | Chichester, West Sussex, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007 |
| Descrizione fisica | 1 online resource (529 p.) |
| Disciplina | 610.28 |
| Altri autori (Persone) |
BrownS. Lori
BrightRoselie A TavrisDale R |
| Soggetto topico |
Medical instruments and apparatus - Standards - United States
Medical instruments and apparatus - Safety measures - United States |
| ISBN |
1-280-95629-1
9786610956296 0-470-06087-5 0-470-06086-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Medical Device Epidemiology and Surveillance; Contents; Foreword; Preface; Contributors; Acknowledgments; 1 Introduction; 2 Medical device regulation in the USA; Introduction; Premarket review; Marketing applications; Postmarket oversight; Conclusion; 3 Medical device epidemiology; Introduction; Features of medical devices that are relevant to epidemiology study design; Study designs for medical device epidemiology; Summary and recommendations; 4 Surveillance of adverse medical device events; Introduction; Rationale for surveillance; Surveillance based on adverse event reports
Surveillance based on registriesActive surveillance; Necessary conditions for effective surveillance; Ideal AMDE surveillance program; Summary; 5 The Medical Product Surveillance Network (MedSun); Historical motivation; Initial considerations for the design of DeviceNet; MedSun basic design; Current status; Is MedSun successful in promoting the safe use of medical devices?; Epidemiologic considerations; Summary; 6 The National Electronic Injury Surveillance System (NEISS) and medical devices; Description and history of NEISS; Potential uses and limitations of NEISS Utilization of NEISS to produce national medical device-associated adverse event estimatesPotential for long-term utilization of NEISS for medical device surveillance; 7 Medical device nomenclature; Technical elements; Current terminologies; Applications of nomenclature; Future developments; 8 Data sources for medical device epidemiology studies and data mining; Introduction; Data sources; Surveillance databases; Registries; Automated large administrative databases; National surveys; Data mining; Future use databases for medical device epidemiology 9 Ethical requirements and guidelines for epidemiological studiesof medical devicesIntroduction; Bioethics foundations; US government human subjects protection regulations; HHS human subjects protection regulatory requirements; FDA human subjects protection regulations; Other professional ethical guidelines; Ethical requirements for medical devices epidemiologic studies; Future ethical requirements for epidemiologic studies; 10 An industry perspective: medical device epidemiology and surveillance; Introduction The product's life cycle: premarket (preclinical and clinical) and postmarket (PM) studiesPostmarket studies; Summary; 11 Perspective from an academic on postmarket surveillance; Introduction; Adverse event reporting; Postmarket condition of approval studies and Section 522 studies; Industry use of information from adverse event reports; Academic opportunities; Summary; 12 Perspective from a pharmacoepidemiologist; Introduction; Review of literature; Contrasts with pharmacopeidemiology; Conclusions; 13 Medical device regulation and surveillance: perspective from the EU; Introduction Medical devices: the European directives and definitions |
| Record Nr. | UNINA-9910831163403321 |
| Chichester, West Sussex, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Medical device epidemiology and surveillance / / editors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris
| Medical device epidemiology and surveillance / / editors, S. Lori Brown, Roselie A. Bright, and Dale R. Tavris |
| Pubbl/distr/stampa | Chichester, West Sussex, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007 |
| Descrizione fisica | 1 online resource (529 p.) |
| Disciplina | 610.28 |
| Altri autori (Persone) |
BrownS. Lori
BrightRoselie A TavrisDale R |
| Soggetto topico |
Medical instruments and apparatus - Standards - United States
Medical instruments and apparatus - Safety measures - United States |
| ISBN |
1-280-95629-1
9786610956296 0-470-06087-5 0-470-06086-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Medical Device Epidemiology and Surveillance; Contents; Foreword; Preface; Contributors; Acknowledgments; 1 Introduction; 2 Medical device regulation in the USA; Introduction; Premarket review; Marketing applications; Postmarket oversight; Conclusion; 3 Medical device epidemiology; Introduction; Features of medical devices that are relevant to epidemiology study design; Study designs for medical device epidemiology; Summary and recommendations; 4 Surveillance of adverse medical device events; Introduction; Rationale for surveillance; Surveillance based on adverse event reports
Surveillance based on registriesActive surveillance; Necessary conditions for effective surveillance; Ideal AMDE surveillance program; Summary; 5 The Medical Product Surveillance Network (MedSun); Historical motivation; Initial considerations for the design of DeviceNet; MedSun basic design; Current status; Is MedSun successful in promoting the safe use of medical devices?; Epidemiologic considerations; Summary; 6 The National Electronic Injury Surveillance System (NEISS) and medical devices; Description and history of NEISS; Potential uses and limitations of NEISS Utilization of NEISS to produce national medical device-associated adverse event estimatesPotential for long-term utilization of NEISS for medical device surveillance; 7 Medical device nomenclature; Technical elements; Current terminologies; Applications of nomenclature; Future developments; 8 Data sources for medical device epidemiology studies and data mining; Introduction; Data sources; Surveillance databases; Registries; Automated large administrative databases; National surveys; Data mining; Future use databases for medical device epidemiology 9 Ethical requirements and guidelines for epidemiological studiesof medical devicesIntroduction; Bioethics foundations; US government human subjects protection regulations; HHS human subjects protection regulatory requirements; FDA human subjects protection regulations; Other professional ethical guidelines; Ethical requirements for medical devices epidemiologic studies; Future ethical requirements for epidemiologic studies; 10 An industry perspective: medical device epidemiology and surveillance; Introduction The product's life cycle: premarket (preclinical and clinical) and postmarket (PM) studiesPostmarket studies; Summary; 11 Perspective from an academic on postmarket surveillance; Introduction; Adverse event reporting; Postmarket condition of approval studies and Section 522 studies; Industry use of information from adverse event reports; Academic opportunities; Summary; 12 Perspective from a pharmacoepidemiologist; Introduction; Review of literature; Contrasts with pharmacopeidemiology; Conclusions; 13 Medical device regulation and surveillance: perspective from the EU; Introduction Medical devices: the European directives and definitions |
| Record Nr. | UNINA-9910877722003321 |
| Chichester, West Sussex, England ; ; Hoboken, NJ, : John Wiley & Sons, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Medical devices : protecting patients and promoting innovation : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, first session ... November 15, 2011
| Medical devices : protecting patients and promoting innovation : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, first session ... November 15, 2011 |
| Pubbl/distr/stampa | Washington : , : U.S. Government Printing Office, , 2014 |
| Descrizione fisica | 1 online resource (iii, 70 pages) : illustrations |
| Collana | S. hrg. |
| Soggetto topico |
Medical instruments and apparatus - Safety regulations - United States
Medical instruments and apparatus - Standards - United States Medical instruments and apparatus - Safety regulations Medical instruments and apparatus - Standards |
| Soggetto genere / forma | Legislative hearings. |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Medical devices |
| Record Nr. | UNINA-9910705464203321 |
| Washington : , : U.S. Government Printing Office, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Medical devices : FDA should expand Its consideration of information security for certain types of devices : report to congressional requesters
| Medical devices : FDA should expand Its consideration of information security for certain types of devices : report to congressional requesters |
| Pubbl/distr/stampa | [Washington, D.C.] : , : United States Government Accountability Office, , 2012 |
| Descrizione fisica | 1 online resource (iii, 62 pages) : illustrations |
| Soggetto topico |
Medical instruments and apparatus - Standards - United States
Medical electronics equipment industry - Standards - United States Medical electronics equipment industry - Information technology - Security measures - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Medical devices |
| Record Nr. | UNINA-9910704354703321 |
| [Washington, D.C.] : , : United States Government Accountability Office, , 2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Soggetto topico
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Medical instruments and apparatus - Standards - United States
(15)
- Medical instruments and apparatus - Safety regulations - United States (6)
- Biological products - Standards - United States (3)
- Drug approval - United States (3)
- Medical instruments and apparatus - Law and legislation - United States (3)