Design controls for the medical device industry:
This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective desig...
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Boca Raton, FL
CRC Press
2020
|
| Ausgabe: | Third edition |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Zusammenfassung: | This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements |
| Beschreibung: | OCLC-licensed vendor bibliographic record |
| Beschreibung: | 1 online resource (xiv, 248 pages) |
| ISBN: | 9781351261487 1351261487 9781351261463 1351261460 9781351261456 1351261452 9781351261470 1351261479 |
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| dewey-full | 610.28 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 610 - Medicine and health |
| dewey-raw | 610.28 |
| dewey-search | 610.28 |
| dewey-sort | 3610.28 |
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| discipline | Medizin |
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| edition | Third edition |
| format | Electronic eBook |
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| illustrated | Not Illustrated |
| index_date | 2024-07-03T14:08:07Z |
| indexdate | 2024-07-10T08:49:28Z |
| institution | BVB |
| isbn | 9781351261487 1351261487 9781351261463 1351261460 9781351261456 1351261452 9781351261470 1351261479 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-032032715 |
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| physical | 1 online resource (xiv, 248 pages) |
| psigel | ZDB-7-TFC |
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| publisher | CRC Press |
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| spelling | Teixeira, Marie B. 1965- Verfasser aut Design controls for the medical device industry Marie B. Teixeira Third edition Boca Raton, FL CRC Press 2020 1 online resource (xiv, 248 pages) txt rdacontent c rdamedia cr rdacarrier OCLC-licensed vendor bibliographic record This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements Medical instruments and apparatus / Design and construction Medical instruments and apparatus industry https://www.taylorfrancis.com/books/9781351261487 Verlag URL des Erstveröffentlichers Volltext |
| spellingShingle | Teixeira, Marie B. 1965- Design controls for the medical device industry Medical instruments and apparatus / Design and construction Medical instruments and apparatus industry |
| title | Design controls for the medical device industry |
| title_auth | Design controls for the medical device industry |
| title_exact_search | Design controls for the medical device industry |
| title_exact_search_txtP | Design controls for the medical device industry |
| title_full | Design controls for the medical device industry Marie B. Teixeira |
| title_fullStr | Design controls for the medical device industry Marie B. Teixeira |
| title_full_unstemmed | Design controls for the medical device industry Marie B. Teixeira |
| title_short | Design controls for the medical device industry |
| title_sort | design controls for the medical device industry |
| topic | Medical instruments and apparatus / Design and construction Medical instruments and apparatus industry |
| topic_facet | Medical instruments and apparatus / Design and construction Medical instruments and apparatus industry |
| url | https://www.taylorfrancis.com/books/9781351261487 |
| work_keys_str_mv | AT teixeiramarieb designcontrolsforthemedicaldeviceindustry |