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Software ALS Medizinprodukt: Entwicklung Und Zulassung Von Software in Der Medizintechnik

Software ALS Medizinprodukt: Entwicklung Und Zulassung Von Software in Der Medizintechnik

          
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About the Book

Lernen Sie mit diesem Buch, wie Sie Software erfolgreich als Medizinprodukt entwickeln und zulassen

Die zunehmende Digitalisierung bringt enorme Fortschritte in der Medizin. Softwarelösungen sind längst ein integraler Bestandteil moderner Medizintechnik. Gleichzeitig verschärft sich die Gesetzgebung für die Entwicklung medizinischer Software zunehmend. Viele Software-Hersteller stehen deshalb vor der Herausforderung, die schnellen Entwicklungen mit der langsameren Bürokratie rund um Gesetzesänderungen in Einklang zu bringen.

Dieses Buch zeigt Ihnen alles, was Sie über die Entwicklung von Software als Medizinprodukt wissen müssen. Die Autoren erläutern die wichtigen Aspekte entlang des Software-Lebenszyklus und helfen Medizintechnikern bei der Formulierung von Softwareanforderungen für Medizinprodukte. Auch die oft Hardware-lastig formulierten Medizintechnik-Normen erklären die Autoren auf leicht verständliche Weise.

Das Buch schlägt eine Brücke zwischen Medizintechnik und IT-Industrie. Neben europäischen Regularien berücksichtigen Mark Hastenteufel und Sina Renaud auch internationale Aspekte.

Einblicke in die Branche und Praxis

Die Autoren geben Ihnen in diesem Buch zunächst einen kurzen Überblick über die wirtschaftliche Bedeutung von Software als Medizinprodukt. Sie klären, warum Medizintechnik ein bedeutender Wirtschaftsfaktor ist und zeigen, was die Branche besonders macht. Anschließend setzen sie sich mit diesen Kernthemen auseinander:

- Die Grundlage: Medical Device Regulation (MDR)

- Die Umsetzung: Normen, Spezifikationen und Guidelines

- Grundlagen des Software Engineerings

- Software als Medizinprodukt

- Zulassungen in den USA

- Ausblick auf weltweite Zulassungen

Damit hilft dieses Buch Medizintechnikern, ihr Wissen über die Digitalisierung auszubauen. Software-Entwicklern erleichtert es den Weg in die Medizintechnik.

Eine Empfehlung, wenn Sie mit den Grundlagen vertraut sind

Leser sollten für das Buch "Software als Medizinprodukt" bereits ein gewisses Grundverständnis im Bereich IT und Softwareentwicklung mitbringen, besonders in Hinblick auf Programmierung und Modellierung. Daher ist dieses Werk auf folgende Zielgruppen ausgerichtet:

a) Dozierende und Studierende der Fachgebiete Software-Engineering, Medizininformatik und -technik

b) Praktiker wie Softwareentwickler, -Projektleiter oder Qualitätsmanager bei Medizintechnikherstellern


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Product Details
  • ISBN-13: 9783658264871
  • Publisher: Springer Fachmedien Wiesbaden
  • Publisher Imprint: Springer Vieweg
  • Height: 240 mm
  • No of Pages: 222
  • Spine Width: 0 mm
  • Weight: 519 gr
  • ISBN-10: 365826487X
  • Publisher Date: 26 Nov 2019
  • Binding: Paperback
  • Language: German
  • Returnable: Y
  • Sub Title: Entwicklung Und Zulassung Von Software in Der Medizintechnik
  • Width: 168 mm


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