TY  - BOOK
AU  - B.Teixeira,Marie
TI  - Design controls for the medical device industry
SN  - 9780815365525 (hardback : alk. paper)
AV  - R856.A2 T45 2020
U1  - 610.28 23
PY  - 2020///
CY  - Boca Raton
PB  - Taylor & Francis
KW  - Medical instruments and apparatus
KW  - Design and construction
KW  - Medical instruments and apparatus industry
N1  - "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
ER  -