Medical device software verification, validation and compliance:
Saved in:
| Main Author: | |
|---|---|
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Boston
Artech House
2011
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| Subjects: | |
| Item Description: | Print version record |
| Physical Description: | 1 online resource (xix, 424 pages) |
| ISBN: | 9781596934238 1596934239 |
Staff View
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| 245 | 1 | 0 | |a Medical device software verification, validation and compliance |c David A. Vogel |
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| 505 | 8 | |a Here's the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software. Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your software's safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process. From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, and in compliance with regulations. Additionally, an entire part of the book is devoted to the validation of software that automates any part of a manufacturer's quality system and is regulated by 21 CFR 820.70(i). DVD Included! Contains a collection of FDA regulations and guidance documents related to software in the medical device industry, valuable sample forms and templates, and supplemental figures that support key topics covered in the book | |
| 650 | 7 | |a MEDICAL / Instruments & Supplies |2 bisacsh | |
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| 650 | 7 | |a Medical instruments and apparatus |2 fast | |
| 650 | 7 | |a Software engineering |2 fast | |
| 650 | 4 | |a Software Validation | |
| 650 | 4 | |a Device Approval / standards | |
| 650 | 4 | |a Software / standards | |
| 650 | 4 | |a Medical instruments and apparatus |v Software |a Software engineering |a Computer software |x Quality control | |
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Record in the Search Index
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| any_adam_object | |
| author | Vogel, David A. |
| author_facet | Vogel, David A. |
| author_role | aut |
| author_sort | Vogel, David A. |
| author_variant | d a v da dav |
| building | Verbundindex |
| bvnumber | BV045344195 |
| classification_rvk | ST 640 XC 4008 |
| collection | ZDB-4-ENC |
| contents | Here's the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software. Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your software's safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process. From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, and in compliance with regulations. Additionally, an entire part of the book is devoted to the validation of software that automates any part of a manufacturer's quality system and is regulated by 21 CFR 820.70(i). DVD Included! Contains a collection of FDA regulations and guidance documents related to software in the medical device industry, valuable sample forms and templates, and supplemental figures that support key topics covered in the book |
| ctrlnum | (ZDB-4-ENC)ocn694732909 (OCoLC)694732909 (DE-599)BVBBV045344195 |
| dewey-full | 610.28/4 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 610 - Medicine and health |
| dewey-raw | 610.28/4 |
| dewey-search | 610.28/4 |
| dewey-sort | 3610.28 14 |
| dewey-tens | 610 - Medicine and health |
| discipline | Informatik Medizin |
| format | Electronic eBook |
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| id | DE-604.BV045344195 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T08:15:30Z |
| institution | BVB |
| isbn | 9781596934238 1596934239 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-030730899 |
| oclc_num | 694732909 |
| open_access_boolean | |
| physical | 1 online resource (xix, 424 pages) |
| psigel | ZDB-4-ENC |
| publishDate | 2011 |
| publishDateSearch | 2011 |
| publishDateSort | 2011 |
| publisher | Artech House |
| record_format | marc |
| spelling | Vogel, David A. Verfasser aut Medical device software verification, validation and compliance David A. Vogel Boston Artech House 2011 1 online resource (xix, 424 pages) txt rdacontent c rdamedia cr rdacarrier Print version record Here's the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software. Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your software's safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process. From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, and in compliance with regulations. Additionally, an entire part of the book is devoted to the validation of software that automates any part of a manufacturer's quality system and is regulated by 21 CFR 820.70(i). DVD Included! Contains a collection of FDA regulations and guidance documents related to software in the medical device industry, valuable sample forms and templates, and supplemental figures that support key topics covered in the book MEDICAL / Instruments & Supplies bisacsh Computer software / Quality control fast Medical instruments and apparatus fast Software engineering fast Software Validation Device Approval / standards Software / standards Medical instruments and apparatus Software Software engineering Computer software Quality control Erscheint auch als Druck-Ausgabe Medical device software verification, validation and compliance Boston : Artech House, 2010 9781596934221 |
| spellingShingle | Vogel, David A. Medical device software verification, validation and compliance Here's the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software. Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your software's safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process. From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, and in compliance with regulations. Additionally, an entire part of the book is devoted to the validation of software that automates any part of a manufacturer's quality system and is regulated by 21 CFR 820.70(i). DVD Included! Contains a collection of FDA regulations and guidance documents related to software in the medical device industry, valuable sample forms and templates, and supplemental figures that support key topics covered in the book MEDICAL / Instruments & Supplies bisacsh Computer software / Quality control fast Medical instruments and apparatus fast Software engineering fast Software Validation Device Approval / standards Software / standards Medical instruments and apparatus Software Software engineering Computer software Quality control |
| title | Medical device software verification, validation and compliance |
| title_auth | Medical device software verification, validation and compliance |
| title_exact_search | Medical device software verification, validation and compliance |
| title_full | Medical device software verification, validation and compliance David A. Vogel |
| title_fullStr | Medical device software verification, validation and compliance David A. Vogel |
| title_full_unstemmed | Medical device software verification, validation and compliance David A. Vogel |
| title_short | Medical device software verification, validation and compliance |
| title_sort | medical device software verification validation and compliance |
| topic | MEDICAL / Instruments & Supplies bisacsh Computer software / Quality control fast Medical instruments and apparatus fast Software engineering fast Software Validation Device Approval / standards Software / standards Medical instruments and apparatus Software Software engineering Computer software Quality control |
| topic_facet | MEDICAL / Instruments & Supplies Computer software / Quality control Medical instruments and apparatus Software engineering Software Validation Device Approval / standards Software / standards Medical instruments and apparatus Software Software engineering Computer software Quality control |
| work_keys_str_mv | AT vogeldavida medicaldevicesoftwareverificationvalidationandcompliance |