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Design controls for the medical device industry / Marie B.Teixeira.

By: Material type: TextTextPublisher: Boca Raton : Taylor & Francis, 2020Edition: Third editionDescription: 263 pages ; 24 cmContent type:
  • text
Media type:
  • unmediated
Carrier type:
  • volume
ISBN:
  • 9780815365525 (hardback : alk. paper)
Subject(s): DDC classification:
  • 610.28 23 T.M.D
LOC classification:
  • R856.A2 T45 2020
Contents:
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"A CRC title, part of the Taylor & Francis imprint, a member of the Taylor & Francis Group, the academic division of T&F Informa plc."

Includes bibliographical references and index.

Introduction --
Device classification --
Overview of design controls --
Design and development planning --
Design inputs: part I --
Design inputs: part II --
Design outputs --
Design review --
Design verification --
Risk management --
Design validation --
Biocompatibility --
Design transfer --
Design change --
Design history file --
The FDA inspection technique

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