Die Neue Verordnung Eu F R Medizinprodukte 2017 745
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Die Neue Verordnung Eu F R Medizinprodukte 2017 745
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Author : Patrick Walitschek
language : de
Publisher: BoD – Books on Demand
Release Date : 2018-10-23
Die Neue Verordnung Eu F R Medizinprodukte 2017 745 written by Patrick Walitschek and has been published by BoD – Books on Demand this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-23 with Technology & Engineering categories.
Mit Inkrafttreten der Medizinprodukteverordnung (EU) 2017/745 (MDR) am 25. Mai 2017 und deren Beginn der Gültigkeit nach einer Übergangszeit von drei Jahren werden neue gesetzliche Vorschriften für die Markteinführung von Medizinprodukten auf dem Markt der Europäischen Union entstehen. Die Geschwindigkeit der Entwicklung der MDR wurde 2012 durch den PIP-Implantatskandal in Frankreich beschleunigt. Die MDR zielt darauf ab, medizinische Geräte für Benutzer und Patienten sicherer und effizienter zu machen. Die neuen regulatorischen Anforderungen üben Druck auf Hersteller, benannte Stellen und Behörden gleichermaßen aus. Diese Arbeit soll die Risiken und Chancen der MDR für Hersteller aktiver Medizinprodukte der Risikoklasse IIa untersuchen. Basierend auf einer Literaturrecherche der geltenden Standards wurden die Risiken und Chancen für Hersteller aktiver Medizinprodukte der Risikoklasse IIa im Vergleich zum konventionellen Verfahren nach Richtlinie 93/42/EWG anhand der Konformitätsbewertung ermittelt. Interviews mit Experten von Behörden, benannten Stellen und Entwicklern geben Informationen über das Bewusstsein der Interessengruppen und praktische Ansätze zur Umsetzung der Anforderungen. Sowohl die Literaturrecherche als auch die Experteninterviews zeigen, dass die Anforderungen, die bereits vor der Einführung des MDR bestanden, erheblich waren und Fragen zur zukünftigen Innovationskraft deutscher und europäischer Medizintechnikunternehmen offenbleiben. Es ist jedoch bereits jetzt klar, dass die Folgen des Inkrafttretens des MDR für Klein- und Kleinstunternehmen dramatisch sein können.
Die Medizinprodukte Verordnung Eu 2017 745
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Author : Boris Handorn
language : de
Publisher: Beuth Verlag GmbH
Release Date : 2021-02-25
Die Medizinprodukte Verordnung Eu 2017 745 written by Boris Handorn and has been published by Beuth Verlag GmbH this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-02-25 with Medical categories.
Für Medizinprodukte gilt ab dem 26. Mai 2021 mit der Verordnung (EU) 2017/745 (Medical Devices Regulation – MDR) ein neuer europäischer Rechtsrahmen. Gegenüber dem bereits hohen Schutzniveau des bisherigen Richtlinienrechts soll die MDR verbesserte Standards für die Qualität und Sicherheit von Medizinprodukten setzen und zugleich einen reibungslos funktionierenden Binnenmarkt sicherstellen. Ein wichtiger Teil dieser neuen Regulierungsvorschriften ist das Konzept der Wirtschaftsakteure, das deutlich klarer als bisher die Rollen und Verantwortlichkeiten bei der Vermarktung von Medizinprodukten definieren soll. Hersteller sowie Inverkehrbringer von Systemen und Behandlungseinheiten, Bevollmächtigte, Importeure und Händler müssen umfangreiche Pflichtenkataloge einhalten. Nicht zuletzt sind damit auch erhöhte Anforderungen an die vertragliche Zusammenarbeit in der Lieferkette und größere Haftungsrisiken für die einzelnen Wirtschaftsakteure verbunden. Dieser Beuth Recht Titel soll einen fundierten Überblick über die neuen Anforderungen aus Sicht der Wirtschaftsakteure bieten und, angesichts der noch zahlreichen Auslegungsfragen, praktische Hinweise für die Umsetzung der MDR geben. Dabei werden stets auch die ergänzenden Vorschriften des Medizinprodukterecht-Durchführungsgesetzes (MPDG), dessen wesentliche Teile in Deutschland mit Geltungsbeginn der MDR in Kraft treten, berücksichtigt.
Mp Vo
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Author : Wolfgang A. Rehmann
language : de
Publisher:
Release Date : 2023-07-31
Mp Vo written by Wolfgang A. Rehmann and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-07-31 with categories.
The Disease Delusion
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Author : Dr. Jeffrey S. Bland
language : en
Publisher: Harper Collins
Release Date : 2014-05-06
The Disease Delusion written by Dr. Jeffrey S. Bland and has been published by Harper Collins this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-05-06 with Health & Fitness categories.
For decades, Dr. Jeffrey Bland has been on the cutting edge of Functional Medicine, which seeks to pinpoint and prevent the cause of illness, rather than treat its symptoms. Managing chronic diseases accounts for three quarters of our total healthcare costs, because we’re masking these illnesses with pills and temporary treatments, rather than addressing their underlying causes, he argues. Worse, only treating symptoms leads us down the path of further illness. In The Disease Delusion, Dr. Bland explains what Functional Medicine is and what it can do for you. While advances in modern science have nearly doubled our lifespans in only four generations, our quality of life has not reached its full potential. Outlining the reasons why we suffer chronic diseases from asthma and diabetes to obesity, arthritis and cancer to a host of other ailments, Dr. Bland offers achievable, science-based solutions that can alleviate these common conditions and offers a roadmap for a lifetime of wellness.
Routledge Handbook Of Water And Health
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Author : Jamie Bartram
language : en
Publisher: Routledge
Release Date : 2015-09-25
Routledge Handbook Of Water And Health written by Jamie Bartram and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-09-25 with Science categories.
This comprehensive handbook provides an authoritative source of information on global water and health, suitable for interdisciplinary teaching for advanced undergraduate and postgraduate students. It covers both developing and developed country concerns. It is organized into sections covering: hazards (including disease, chemicals and other contaminants); exposure; interventions; intervention implementation; distal influences; policies and their implementation; investigative tools; and historic cases. It offers 71 analytical and engaging chapters, each representing a session of teaching or graduate seminar. Written by a team of expert authors from around the world, many of whom are actively teaching the subject, the book provides a thorough and balanced overview of current knowledge, issues and relevant debates, integrating information from the environmental, health and social sciences.
Clinical Engineering Handbook
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Author : Joseph F. Dyro
language : en
Publisher: Academic Press
Release Date : 2004-08-27
Clinical Engineering Handbook written by Joseph F. Dyro and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-08-27 with Medical categories.
As the biomedical engineering field expands throughout the world, clinical engineers play an ever more important role as the translator between the worlds of the medical, engineering, and business professionals. They influence procedure and policy at research facilities, universities and private and government agencies including the Food and Drug Administration and the World Health Organization. Clinical engineers were key players in calming the hysteria over electrical safety in the 1970s and Y2K at the turn of the century and continue to work for medical safety. This title brings together all the important aspects of Clinical Engineering. It provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world.
Pharmaceutical Medicine Biotechnology And European Law
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Author : Richard Goldberg
language : en
Publisher: Cambridge University Press
Release Date : 2000
Pharmaceutical Medicine Biotechnology And European Law written by Richard Goldberg and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000 with Law categories.
Lawyers and academics reassess the impact of European law on health care and pharmaceutical law.
Praktische Krankenhaushygiene Und Umweltschutz
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Author :
language : de
Publisher:
Release Date :
Praktische Krankenhaushygiene Und Umweltschutz written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
Artificial Intelligence For Covid 19
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Author : Diego Oliva
language : en
Publisher: Springer Nature
Release Date : 2021-07-19
Artificial Intelligence For Covid 19 written by Diego Oliva and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-07-19 with Technology & Engineering categories.
This book presents a compilation of the most recent implementation of artificial intelligence methods for solving different problems generated by the COVID-19. The problems addressed came from different fields and not only from medicine. The information contained in the book explores different areas of machine and deep learning, advanced image processing, computational intelligence, IoT, robotics and automation, optimization, mathematical modeling, neural networks, information technology, big data, data processing, data mining, and likewise. Moreover, the chapters include the theory and methodologies used to provide an overview of applying these tools to the useful contribution to help to face the emerging disaster. The book is primarily intended for researchers, decision makers, practitioners, and readers interested in these subject matters. The book is useful also as rich case studies and project proposals for postgraduate courses in those specializations.
A Life Course Approach To Healthy Ageing
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Author : Diana Kuh
language : en
Publisher: OUP Oxford
Release Date : 2013-12-19
A Life Course Approach To Healthy Ageing written by Diana Kuh and has been published by OUP Oxford this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-12-19 with Medical categories.
Healthy ageing has long been a neglected area of epidemiological research as the traditional focus has been on specific chronic diseases of older life. There is a growing consensus from scientists, research funders and policy makers that ageing itself needs to be studied from an interdisciplinary and life course perspective, to inform strategies for reducing the societal and individual costs of an ageing population. A Life Course Approach to Healthy Ageing is a synthesis of life course perspectives in epidemiology and interdisciplinary perspectives in ageing research. It brings together expert investigators of maturing birth cohort and ageing studies, cross-cutting methodologists, and authorities in ageing research and knowledge transfer from across the world in one wide-ranging volume. Contributors discuss how aspects of healthy ageing are conceptualised, defined and measured; relate to each other; change across life; and are influenced by biological, psychological and social factors operating from early life onwards. They identify research gaps, and suggest how evidence from observational studies can be strengthened through improved study design and longitudinal analysis, thereby increasing the research contribution to practice or policy change. The book considers how we might delay or slow down the progressive, generalised impairment of function that occurs at the individual, body system and cellular levels, as people grow older. It also considers the determinants of wellbeing in older people, including personal fulfilment, positive emotions and social relationships. Broad in scope, discussing topics from genetics to psychological and social wellbeing, A Life Course Approach to Healthy Ageing is a key resource for epidemiologists, social scientists, clinicians, public health physicians, policy makers and practitioners with a research interest in healthy ageing.