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The Resource The FDA and worldwide quality system requirements guidebook for medical devices, compiled and written by Amiram Daniel & Ed Kimmelman, (electronic book)

The FDA and worldwide quality system requirements guidebook for medical devices, compiled and written by Amiram Daniel & Ed Kimmelman, (electronic book)

Label
The FDA and worldwide quality system requirements guidebook for medical devices
Title
The FDA and worldwide quality system requirements guidebook for medical devices
Statement of responsibility
compiled and written by Amiram Daniel & Ed Kimmelman
Creator
Contributor
Subject
Genre
Language
eng
Summary
"This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, and the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents." "This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization's QMS, QMS issues related to continuation products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities."--BOOK JACKET
Cataloging source
KNOVL
http://library.link/vocab/creatorName
Daniel, Amiram
Dewey number
344.7304/2
Index
index present
LC call number
KF3827.M4
LC item number
T73 2008eb
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorDate
1964-
http://library.link/vocab/relatedWorkOrContributorName
  • Kimmelman, Ed
  • Trautman, Kimberly A.
http://library.link/vocab/subjectName
  • Medical instruments and apparatus industry
  • Quality control
  • Medical instruments and apparatus industry
  • Medical instruments and apparatus industry
  • Quality control
  • Medical instruments and apparatus industry
  • Device Approval
  • Equipment and Supplies
  • Equipment Safety
  • Government Regulation
  • Guidelines as Topic
  • Quality Control
  • USA
Label
The FDA and worldwide quality system requirements guidebook for medical devices, compiled and written by Amiram Daniel & Ed Kimmelman, (electronic book)
Instantiates
Publication
Note
  • Includes index
  • Rev. ed. of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. c1997
Antecedent source
unknown
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Dimensions
unknown
Edition
2nd ed.
Extent
1 online resource (xxx, 304 p.)
File format
unknown
Form of item
online
Isbn
9781621982067
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Quality assurance targets
not applicable
Reformatting quality
unknown
Reproduction note
Electronic resource.
Sound
unknown sound
Specific material designation
remote
Label
The FDA and worldwide quality system requirements guidebook for medical devices, compiled and written by Amiram Daniel & Ed Kimmelman, (electronic book)
Publication
Note
  • Includes index
  • Rev. ed. of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. c1997
Antecedent source
unknown
Carrier category
online resource
Carrier category code
  • cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
  • txt
Content type MARC source
rdacontent
Dimensions
unknown
Edition
2nd ed.
Extent
1 online resource (xxx, 304 p.)
File format
unknown
Form of item
online
Isbn
9781621982067
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
  • c
Quality assurance targets
not applicable
Reformatting quality
unknown
Reproduction note
Electronic resource.
Sound
unknown sound
Specific material designation
remote

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