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)
Resource Information
The item The FDA and worldwide quality system requirements guidebook for medical devices, compiled and written by Amiram Daniel & Ed Kimmelman, (electronic book) represents a specific, individual, material embodiment of a distinct intellectual or artistic creation found in Sydney Jones Library, University of Liverpool.This item is available to borrow from 1 library branch.
Resource Information
The item The FDA and worldwide quality system requirements guidebook for medical devices, compiled and written by Amiram Daniel & Ed Kimmelman, (electronic book) represents a specific, individual, material embodiment of a distinct intellectual or artistic creation found in Sydney Jones Library, University of Liverpool.
This item is available to borrow from 1 library branch.
- 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
- Language
- eng
- Edition
- 2nd ed.
- Extent
- 1 online resource (xxx, 304 p.)
- Note
-
- Includes index
- Rev. ed. of: FDA and worldwide quality system requirements guide book for medical devices / Kimberly A. Trautman. c1997
- Isbn
- 9781621982067
- 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
- Subject
-
- Equipment Safety -- standards -- United States -- Guideline
- Equipment and Supplies -- standards -- United States -- Guideline
- Government Regulation -- United States -- Guideline
- Guidelines as Topic -- United States -- Guideline
- Medical instruments and apparatus industry -- Law and legislation
- Medical instruments and apparatus industry -- Law and legislation -- United States
- Medical instruments and apparatus industry -- Quality control
- Medical instruments and apparatus industry -- United States -- Quality control
- Quality Control -- United States -- Guideline
- Quality control -- Law and legislation
- Quality control -- Law and legislation -- United States
- USA
- Device Approval -- legislation & jurisprudence -- United States -- Guideline
- 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)
- 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)
- 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
Subject
- Equipment Safety -- standards -- United States -- Guideline
- Equipment and Supplies -- standards -- United States -- Guideline
- Government Regulation -- United States -- Guideline
- Guidelines as Topic -- United States -- Guideline
- Medical instruments and apparatus industry -- Law and legislation
- Medical instruments and apparatus industry -- Law and legislation -- United States
- Medical instruments and apparatus industry -- Quality control
- Medical instruments and apparatus industry -- United States -- Quality control
- Quality Control -- United States -- Guideline
- Quality control -- Law and legislation
- Quality control -- Law and legislation -- United States
- USA
- Device Approval -- legislation & jurisprudence -- United States -- Guideline
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<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.liverpool.ac.uk/portal/The-FDA-and-worldwide-quality-system-requirements/79eKQo-aFIs/" typeof="Book http://bibfra.me/vocab/lite/Item"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.liverpool.ac.uk/portal/The-FDA-and-worldwide-quality-system-requirements/79eKQo-aFIs/">The FDA and worldwide quality system requirements guidebook for medical devices, compiled and written by Amiram Daniel & Ed Kimmelman, (electronic book)</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.liverpool.ac.uk/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.liverpool.ac.uk/">Sydney Jones Library, University of Liverpool</a></span></span></span></span></div>
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<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.liverpool.ac.uk/portal/The-FDA-and-worldwide-quality-system-requirements/79eKQo-aFIs/" typeof="Book http://bibfra.me/vocab/lite/Item"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.liverpool.ac.uk/portal/The-FDA-and-worldwide-quality-system-requirements/79eKQo-aFIs/">The FDA and worldwide quality system requirements guidebook for medical devices, compiled and written by Amiram Daniel & Ed Kimmelman, (electronic book)</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.liverpool.ac.uk/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.liverpool.ac.uk/">Sydney Jones Library, University of Liverpool</a></span></span></span></span></div>
