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B.Teixeira, Marie.

Design controls for the medical device industry / Marie B.Teixeira. - Third edition. - 263 pages ; 24 cm

"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

ISBN: 9780815365525 (hardback : alk. paper)

LCCN: 2019015738

Subjects--Topical Terms:
Medical instruments and apparatus--Design and construction.
Medical instruments and apparatus industry.

LC Class. No.: R856.A2 / T45 2020

Dewey Class. No.: 610.28 / T.M.D