Design controls for the medical device industry

"Design control is a key element of a company's quality management system and is mandated by the U.S. FDA's Quality System Regulation under article 820.30 for most medical devices. Medical device companies wishing to comply with ISO 13485 to meet international requirements are also su...

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Bibliographic Details
Main Author Teixeira, Marie B., 1965- (Author)
Format Electronic eBook
LanguageEnglish
Published Boca Raton : Taylor & Francis, [2013]
EditionSecond edition.
Subjects
Medical instruments and apparatus > Design and construction.
Medical instruments and apparatus industry.
Quality control.
elektronické knihy
electronic books
Online AccessFull text
ISBN9781466503557
1466503556
9781628707120
1628707127
9781466503540
1466503548
Physical Description1 online resource

Cover

Table of Contents:
  • 1. Introduction
  • 2. Device classification
  • 3. Overview of design controls
  • 4. Design and development planning
  • 5. Design inputs : part I
  • 6. Design inputs : part II
  • 7. Design outputs
  • 8. Design review
  • 9. Design verification
  • 10. Risk management
  • 11. Design validation
  • 12. Biocompatibility
  • 13. Design transfer
  • 14. Design change
  • 15. Design history file
  • 16. The FDA inspection technique.

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