Design Controls for the Medical Device Industry

Published:
September 20, 2002 by CRC Press - 254 Pages
Author(s):
Marie B. Teixeira, QA/RA Compliance Connection, Inc., Odessa, Florida, USA; Marie B. Teixeira; Richard Bradley, Global Consulting Network, Inc., Palm Harbor, Florida, USA

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Hardback
$199.95
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ISBN 9780824708306
Cat# DK5666
 

Summary

This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems.

Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit.

Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to

  • prepare for an FDA audit
  • identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies
  • determine the compatibility of design specifications and manufacturing, installation, and servicing demands
  • ensure that proper design, function, and performance stipulations are understood and met
  • verify and validate design criteria and production schemes
  • eliminate confusion and prevent communication breakdowns
  • allocate and conserve resources
  • perform risk assessment analyses
  • predict potential hazards under normal and fault conditions
    Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.

    • Table of Contents

    Overview; design and development planning; design input I; design input II; design outputs; design review; design verification; design validation; process validation; design transfer; design changes; the design history file; questions to expect in an audit.

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