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  3. Publications "Usability Engineering als Erfolgsfaktor; Effizient DIN EN 62366-1- und FDA-konform dokumentieren"
Publications Usability Engineering als Erfolgsfaktor; Effizient DIN EN 62366-1- und FDA-konform dokumentieren 16.12.2020 preview

Usability Engineering als Erfolgsfaktor; Effizient DIN EN 62366-1- und FDA-konform dokumentieren

Usability Engineering als Erfolgsfaktor; Effizient DIN EN 62366-1- und FDA-konform dokumentieren

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Designation: Usability Engineering als Erfolgsfaktor; Effizient DIN EN 62366-1- und FDA-konform dokumentieren
Approximate weight : 300 g (0.66 lbs)
Note: Multiple-component retail product, Library binding
Publication date: 16.12.2020
Country: German publication
Category: German publications
*) If the goods is not available in stock and must be ordered at the publisher, the actual shipping and handling costs will be added. We will inform you about the details based on your request sent to info@normservis.cz, eventually dialing +420 566 621 759.

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Annotation of standard text:

Der Praxis-Band "Usability Engineering als Erfolgsfaktor" erläutert konkret, welche Informationen im Rahmen der Anforderungen der DIN EN 62366-1 und der FDA für ein Medizinprodukt dokumentiert werden müssen und in welcher Form das am besten geschieht (Verzahnung von Regulatory Affairs und Usability-Engineering). Die zweite Auflage basiert auf der aktuellen Ausgabe der Norm zur Gebrauchstauglichkeit von Medizinprodukten DIN EN 62366-1:2017-07 einschl. des Amendements. Sie berücksichtigt neben den Anforderungen der neuen EU-Medizinprodukteverordnung MDR auch Aspekte des Risikomanagements (DIN EN ISO 14971) und der Ergonomie (DIN EN ISO 9241-11).

Product Type:Multiple-component retail product, Library binding
ISBN: 9783410293019
Publisher:DIN Media GmbH
Edition:.aktualisierte Ausgabe
Language:ger
Note:Unit weight: 440 gr, Width: 148 mm, Height: 210 mm

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