Safety of Electromedical Devices : Law Risks Opportunities

The book discusses the legal and technical requirements for manufacturers, designers and testers of electromedical devices. It describes which obstacles must be overcome to introduce a medical device on the European market, but also informs readers as to pitfalls and opportunities, and in which way...

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Détails bibliographiques
Auteur principal: Leitgeb, Norbert
Format: Livre numérique
Langue:Anglais
Publié: Vienna : Springer Vienna [20..].
Cham : Springer Nature
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Note: Archives Springer e-books (Licence nationale)
Archives Springer e-books (Licence nationale)
Autres localisations: Voir dans le Sudoc
Edition sous un autre format:• Safety of Electromedical Devices, Texte imprimé, 9783211996874
• Safety of electromedical devices, law - risks - opportunities, Norbert Leitgeb, 2010, Wien, Springer, 1 vol. (XI-233 p.), 978-3-211-99682-9
Description
Résumé:The book discusses the legal and technical requirements for manufacturers, designers and testers of electromedical devices. It describes which obstacles must be overcome to introduce a medical device on the European market, but also informs readers as to pitfalls and opportunities, and in which way safety can be achieved and product liability limited. It explains how the newly required risk management process, which comprises risk analysis, risk assessment, risk management and risk control, can be implemented. As a final essential consideration, the book describes which safety requirements are to be met and how they can be satisfied and tested.
Description:Archives Springer e-books (Licence nationale)
Archives Springer e-books (Licence nationale)
ISBN:9783211996836
Accès:Accès en ligne pour les établissements français bénéficiaires des licences nationales
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Conditions particulières de réutilisation pour les bénéficiaires des licences nationales. https://www.licencesnationales.fr/springer-nature-ebooks-contrat-licence-ln-2017