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Publication Beuth Pocket 2019-02

FDA Quality System Regulation

FDA Quality System Regulation - 21 CFR Part 820

Authors
Dipl.-Ing. (FH) MBA Arne Briest
Publisher
DIN
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  • 30.00 EUR

Book
  • 30.00 EUR

eBook + book combo 1
  • 39.00 EUR

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Authors
Dipl.-Ing. (FH) MBA Arne Briest
Publisher
DIN

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About this product

The Quality System Regulation (QSR) is an expansion of the Good Manufacturing Practice (GMP) in which the US Food and Drug Administration (FDA) lays down requirements on medical devices for use in humans. The QSR is more detailed in many respects and applies to a wider range of applications; it is similar to ISO 13485, but not identical. This book includes the original text in English and the German translation of the legislation. It provides manufacturers and users of medical devices with an essential and detailed guideline for the legally compliant use of such products. In this current second edition, the updates to the 2018 QSR have been incorporated.

State-of-the-art legal certainty and US medical standards

The German translation of the QSR fills a gap and will make it easier for German-speaking users to understand and apply the requirements specified in this legislation. This is particularly important for companies that do business with American firms. The following topics are covered in the “Quality System Regulation”:

  • Applied processes
    Process controls, process validation, inspection, measuring and test equipment etc.
  • Facilities used
  • Controls for each of the steps
    Design, manufacturing, packaging, labeling, storage, installation and servicing

The book’s layout has been designed with ease of use in mind. The original English text is in one column and the German translation is in a second, adjacent column in a different colour. The handy format of this book makes the translation particularly user-friendly.

What is new compared to the previous edition?

Changes in the text of the QSR have been incorporated and errors in the translation have been corrected.

Topics included

  • General provisions
  • Quality system requirements
  • Design controls
  • Document controls
  • Purchasing information
  • Identification and traceability
  • Production and process controls
  • Acceptance activities
  • Defective products
  • Corrective and preventive activities
  • Identification and packaging controls
  • Handling, storage, distribution, and installation
  • Records
  • Maintenance/servicing
  • Statistical techniques

Target readership:
Manufacturers, users and examiners/examining bodies in the area of products and devices for human medicine

Product information
Publication date:: 02.2019

2. updated Edition, 80 Pages, 21,0×10,5 cm, Paper covers

ISBN 978-3-410-28808-4 | Order number 28808

eBook 978-3-410-28809-1 | Order number 28809

Details about the publisher and authors

Authors

  • Dipl.-Ing. (FH) MBA Arne Briest

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