Class 1 devices : case studies in medical devices design /

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The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented direct...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Ogrodnik, Peter J. (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London ; San Diego, CA : Academic Press, [2015]
Temas:
Medical instruments and apparatus > Design and construction.
Medical instruments and apparatus > Design and construction
Acceso en línea:Texto completo

MARC

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049 |a UAMI 
100 1 |a Ogrodnik, Peter J.,  |e author. 
245 1 0 |a Class 1 devices :  |b case studies in medical devices design /  |c Peter J. Ogrodnik. 
246 3 0 |a Case studies in medical devices design 
264 1 |a London ;  |a San Diego, CA :  |b Academic Press,  |c [2015] 
264 4 |c ©2015 
300 |a 1 online resource (1 volume) :  |b illustrations 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
588 0 |a Online resource; title from title page (Safari, viewed February 5, 2015). 
504 |a Includes bibliographical references. 
505 0 |a Cover; Title Page; Copyright Page; Dedication; Contents; Acknowledgements; Chapter 1 -- Introduction; 1.1 -- Reminder concerning classification; 1.2 -- A reminder concerning the importance of design rigour (or design control); 1.3 -- A reminder concerning understanding the problem; 1.4 -- A reminder concerning a team/holistic approach; 1.5 -- A reminder concerning costs; 1.6 -- Introduction to the case studies; Case Study: The OTC Joint Support; Case Study: Surgical Wire Cutters; Case Study: Orthopaedic Cast; 1.6.1 -- Comments Concerning the Case Studies. 
505 8 |a 1.7 -- Hints to enable you to understand the textChapter 2 -- Classification; 2.1 -- Introduction; 2.1.1 -- Timing; 2.2 -- FDA classification; 2.2.1 -- Keywords; 2.3 -- EU MDD classification; 2.4 -- Your turn; Chapter 3 -- Taking the Design from Idea to PDS; 3.1 -- Introduction; 3.2 -- Developing the specification; 3.2.1 -- The Need; 3.2.2 -- The PDS; 3.2.3 -- Customer Section; 3.2.4 -- Regulatory and Statutory Section; 3.2.5 -- Technical Section and Performance Section; 3.2.6 -- Sales Section; 3.2.7 -- Manufacturing Section; 3.2.8 -- Packaging and Transportation Section; 3.2.9 -- Environmental Section. 
505 8 |a Chapter 4 -- Conceptual Phase4.1 -- A reminder about space; 4.2 -- The relationship with your product design specification (PDS); 4.3 -- Solution selection; 4.3.1 -- Initial Screening (optional); 4.3.2 -- Detailed Selection (Essential); 4.4 -- Summary; Chapter 5 -- Embodiment Phase; 5.1 -- A reminder about this phase; 5.2 -- Initial embodiment -- or first prototype phase; 5.2.1 -- Detailed Drawings and Specifications of Components; 5.2.2 -- Calculations/Simulations Demonstrating Performance and Quality in Design; 5.2.2.1 -- FMEA; 5.2.2.2 -- Optimisation; 5.2.2.3 -- Design for X. 
505 8 |a 5.2.2.4 -- Validation and Verification5.2.2.5 -- Design for Manufacture; 5.3 -- Prototype to final design; 5.3.1 -- Link Between this Stage and the Previous Stage; 5.3.2 -- Detailed Drawings and Specifications; 5.3.2.1 -- A Reminder About Logging Modifications; 5.3.2.2 -- Transition from FMEA to Risk Analysis (RA); 5.3.2.3 -- Essential Requirements (Especially for EU); 5.3.2.4 -- Validation, Verification and Clinical Evaluation; 5.3.2.5 -- IFUs, Labelling, Other Instructions and Markings; 5.4 -- Summary; Chapter 6 -- The Home Run; 6.1 -- A summary of activity; 6.2 -- The technical file. 
505 8 |a 6.3 -- A note about manufacturing6.4 -- A note about post market surveillance (PMS); 6.5 -- The final furlong; 6.5.1 -- EU; 6.5.2 -- FDA; 6.6 -- Continual improvement; References; I -- Essential Requirements; I -- General requirements; II -- Requirements regarding design and construction. 
520 |a The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a com. 
590 |a ProQuest Ebook Central  |b Ebook Central Academic Complete 
650 0 |a Medical instruments and apparatus  |x Design and construction. 
650 7 |a Medical instruments and apparatus  |x Design and construction  |2 fast 
776 0 8 |i Print version:  |a Ogrodnik, Peter J.  |t Class 1 Devices : Case Studies in Medical Devices Design.  |d Burlington : Elsevier Science, ©2014  |z 9780128000281 
856 4 0 |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=1882921  |z Texto completo 
938 |a EBL - Ebook Library  |b EBLB  |n EBL1882921 
938 |a YBP Library Services  |b YANK  |n 12190320 
994 |a 92  |b IZTAP 

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