Carol V. (Toft, Minnesota, USA) Desain,
Carol V. Desain,
Charmaine V. (The Tamarack Group-MPLS, LLC, Maple Grove, Minnesota, USA) Sutton,
Charmaine V. Sutton
e.a.
Validation for Medical Device and Diagnostic Manufacturers
Gebonden Engels 1997 2e druk 9781574910636
Verwachte levertijd ongeveer 11 werkdagen
Samenvatting
Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies must demonstrate that product design, process, and test methods/requirements/specifications determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR.
Specificaties
Lezersrecensies
Wees de eerste die een lezersrecensie schrijft!
Rubrieken
- advisering
- algemeen management
- coaching en trainen
- communicatie en media
- economie
- financieel management
- inkoop en logistiek
- internet en social media
- it-management / ict
- juridisch
- leiderschap
- marketing
- mens en maatschappij
- non-profit
- ondernemen
- organisatiekunde
- personal finance
- personeelsmanagement
- persoonlijke effectiviteit
- projectmanagement
- psychologie
- reclame en verkoop
- strategisch management
- verandermanagement
- werk en loopbaan