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ISO 13485 : a complete guide to quality management in the medical device industry / Itay Abuhav.

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Author/Creator:
Abuhav, Itay.
Language:
English.
Publication date:
2012
Imprint:
Boca Raton : CRC Press/Taylor & Francis, c2012.
Format:
  • Book
  • xi, 361 p. : ill. ; 24 cm.
Note:
Includes index.
Contents:
  • Scope
  • Normative references
  • Terms and definitions
  • Quality management system
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis, and improvement.
Summary:
"The United States and European Union now require the ISO 13485 Standard certification for medical device manufacturers. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 standard certification for medical device manufacturing in terms of quality control. It covers all the requirements of ISO 13485 and offers a step-by-step comparison between the ISO 13485 and ISO 9001, enabling a sound understanding of these new procedures"--Provided by publisher.
Subjects:
ISBN:
9781439866115
1439866112

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