L'harmonisation internationale des réglementations relatives aux dispositifs médicaux de diagnostic in vitro PDF Download

Author: Laurence Bruel
Publisher:
ISBN:
Category :
Languages : fr
Pages : 0

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Book Description
Un Dispositif Médical de diagnostic in Vitro (DMDIV) est un produit ou instrument destiné par son fabricant à être utilisé in vitro dans l'examen d'échantillons provenant du corps humain, dans le but notamment de fournir une information sur l'état physiologique ou pathologique d'une personne ou sur une anomalie congénitale. La commercialisation des DMDIV sur la marché international s'inscrit aujourd'hui dans un contexte de plus en plus exigeant notamment sur la sécurité et la performance du dispositif. Or la règlementation relative à la commercialisation de ce type de produit est spécifique à chaque pays. C'est dans ce contexte qu'a été crée en 1992, le Global Harmonisation Task Force (GHTF), un groupe composé de représentants volontaires issus des cinq membres fondateurs (l'Union Européenne, les Etats-Unis, le Japon, le Canada et l'Australie) qui s'est fixé pour objectif de promouvoir la convergence des exigences réglementaires des pays autour des DM et des DMDIV. L'objectif de la thèse est de faire le point sur les réglementations de chacun des pays membres, en ciblant certains éléments ayant fait l'objet de recommandations du GHTF (définition, classification, procédure d'évaluation de la conformité, STED, surveillance post-commercialisation, et étiquetage) afin de déterminer dans quelle mesure ces recommandations ont influencé les réglementations nationales à ce jour et d'évaluer le niveau de convergence actuel et l'intérêt des travaux du GHTF.

Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 36

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Author: Alan D. Lopez
Publisher: World Bank Publications
ISBN: 0821362631
Category : Medical
Languages : en
Pages : 511

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Book Description
Strategic health planning, the cornerstone of initiatives designed to achieve health improvement goals around the world, requires an understanding of the comparative burden of diseases and injuries, their corresponding risk factors and the likely effects of invervention options. The Global Burden of Disease framework, originally published in 1990, has been widely adopted as the preferred method for health accounting and has become the standard to guide the setting of health research priorities. This publication sets out an updated assessment of the situation, with an analysis of trends observed since 1990 and a chapter on the sensitivity of GBD estimates to various sources of uncertainty in methods and data.

Author: Itay Abuhav
Publisher: CRC Press
ISBN: 1351000772
Category : Medical
Languages : en
Pages : 735

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Book Description
Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.

Author: Gesellschaft für Biologische Chemie. Colloquium
Publisher:
ISBN:
Category : Hormone receptors
Languages : en
Pages : 224

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Author: Wangari Maathai
Publisher: Anchor
ISBN: 0307378098
Category : Political Science
Languages : en
Pages : 337

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Book Description
In this groundbreaking work, the Nobel Peace Prize-winner and founder of the Green Belt Movement offers a new perspective on the troubles facing Africa today. Too often these challenges are portrayed by the media in extreme terms connoting poverty, dependence, and desperation. Wangari Maathai, the author of Unbowed, sees things differently, and here she argues for a moral revolution among Africans themselves. Illuminating the complex and dynamic nature of the continent, Maathai offers “hardheaded hope” and “realistic options” for change and improvement. She deftly describes what Africans can and need to do for themselves, stressing all the while responsibility and accountability. Impassioned and empathetic, The Challenge for Africa is a book of immense importance.

Author: Edward Steinfeld
Publisher: Springer Science & Business Media
ISBN: 9780306458910
Category : Architecture
Languages : en
Pages : 446

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Book Description
This collection focuses on methods for measuring the role of the physical environment in the disablement process and the limitations of current theory, knowledge, and research in the field. Linking the chapters is a new paradigm of research on accessibility, which emphasizes that disability is both a social and an individual process and is consistent with recent developments in a disability rights, rehabilitation practice, and environmental design.

Author: Christina Maslach
Publisher: John Wiley & Sons
ISBN: 0470423560
Category : Psychology
Languages : en
Pages : 200

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Book Description
Today's workforce is experiencing job burnout in epidemic proportions. Workers at all levels, both white- and blue-collar, feel stressed out, insecure, misunderstood, undervalued, and alienated at their workplace. This original and important book debunks the common myth that when workers suffer job burnout they are solely responsible for their fatigue, anger, and don't give a damn attitude. The book clearly shows where the accountability often belongs. . . .squarely on the shoulders of the organization.

Author: European Federation for Medical Informatics
Publisher: IOS Press
ISBN: 1614991014
Category : Medical
Languages : en
Pages : 1284

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Book Description
Medical informatics and electronic healthcare have many benefits to offer in terms of quality of life for patients, healthcare personnel, citizens and society in general. But evidence-based medicine needs quality information if it is to lead to quality of health and thus to quality of life. This book presents the full papers accepted for presentation at the MIE2012 conference, held in Pisa, Italy, in August 2012. The theme of the 2012 conference is ‘Quality of Life through Quality of Information’. As always, the conference provides a unique platform for the exchange of ideas and experiences among the actors and stakeholders of ICT supported healthcare. The book incorporates contributions related to the latest achievements in biomedical and health informatics in terms of major challenges such as interoperability, collaboration, coordination and patient-oriented healthcare at the most appropriate level of care. It also offers new perspectives for the future of biomedical and health Informatics, critical appraisal of strategies for user involvement, insights for design, deployment and the sustainable use of electronic health records, standards, social software, citizen centred e-health, and new challenges in rehabilitation and social care informatics. The topics presented are interdisciplinary in nature and will be of interest to a variety of professionals; physicians, nurses and other allied health providers, health informaticians, engineers, academics and representatives from industry and consultancy in the various fields.

Author: Toyin Falola
Publisher: Routledge
ISBN: 1135212880
Category : Literary Criticism
Languages : en
Pages : 454

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Book Description
This volume brings together insights from distinguished scholars from around the world to address the facts, fiction and creative imaginations in the pervasive portrayals of Africa, its people, societies and cultures in the literature and the media. The fictionalization of Africa and African issues in the media and the popular literature that blends facts and fiction has rendered perceptions of Africa, its cultures, societies, customs, and conflicts often superficial and deficient in the popular Western consciousness. The book brings eminent scholars from a variety of disciplines to sort out the persistent fictionalization of Africa, from facts pertaining to the genesis of powerful cultural, political or religious icons, the historical and cultural significance of "intriguing" customs (such as tribal marks), gender relations, causes of conflicts and African responses, and creative imaginations in contemporary African films, fiction and literature, among others.