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The Development of Medical Devices
Ethical, Legal and Methodological Impacts of the EU Medical Device Regulation
Taschenbuch von Dirk Lanzerath (u. a.)
Sprache: Englisch

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Beschreibung
Medical devices include objects, substances and software that are used for therapeutic or diagnostic purposes for humans. However, the main intended effect, in contrast to medicinal products, is not primarily pharmacological, metabolic or immunological, but usually physical or physicochemical. The innovation cycles for many modern implantable medical devices are estimated to be about 18 months, for software even shorter. It is obvious that the evaluation of the performance, the effectiveness, the benefits and risks of a medical devices is very different compared to medicinal products. The recent EU-Regulation on medical devices asks for very requirements regarding the systematic evaluation of medical devices in humans and the procedures for granting the CE mark. The recent volume of the series MEDICAL ETHICS addresses the ethical, legal, methodological, and practical challenges arising from the Regulation regarding the development and use of medical devices.
Medical devices include objects, substances and software that are used for therapeutic or diagnostic purposes for humans. However, the main intended effect, in contrast to medicinal products, is not primarily pharmacological, metabolic or immunological, but usually physical or physicochemical. The innovation cycles for many modern implantable medical devices are estimated to be about 18 months, for software even shorter. It is obvious that the evaluation of the performance, the effectiveness, the benefits and risks of a medical devices is very different compared to medicinal products. The recent EU-Regulation on medical devices asks for very requirements regarding the systematic evaluation of medical devices in humans and the procedures for granting the CE mark. The recent volume of the series MEDICAL ETHICS addresses the ethical, legal, methodological, and practical challenges arising from the Regulation regarding the development and use of medical devices.
Details
Erscheinungsjahr: 2021
Genre: Politikwissenschaft & Soziologie
Rubrik: Wissenschaften
Medium: Taschenbuch
Seiten: 168
Inhalt: 168 S.
ISBN-13: 9783643912602
ISBN-10: 3643912609
Sprache: Englisch
Redaktion: Lanzerath, Dirk
Kielmansegg, Sebastian von
Hasford, Joerg
Herausgeber: Dirk Lanzerath/Sebastian Graf von Kielmansegg/Joerg Hasford
Hersteller: LIT Verlag
Maße: 11 x 165 x 238 mm
Von/Mit: Dirk Lanzerath (u. a.)
Erscheinungsdatum: 23.02.2021
Gewicht: 0,318 kg
preigu-id: 117982615
Details
Erscheinungsjahr: 2021
Genre: Politikwissenschaft & Soziologie
Rubrik: Wissenschaften
Medium: Taschenbuch
Seiten: 168
Inhalt: 168 S.
ISBN-13: 9783643912602
ISBN-10: 3643912609
Sprache: Englisch
Redaktion: Lanzerath, Dirk
Kielmansegg, Sebastian von
Hasford, Joerg
Herausgeber: Dirk Lanzerath/Sebastian Graf von Kielmansegg/Joerg Hasford
Hersteller: LIT Verlag
Maße: 11 x 165 x 238 mm
Von/Mit: Dirk Lanzerath (u. a.)
Erscheinungsdatum: 23.02.2021
Gewicht: 0,318 kg
preigu-id: 117982615
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