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Author Ogrodnik, Peter J., author.

Title Class 1 devices : Case studies in medical devices design / Peter J. Ogrodnik.

Publication Info. Amsterdam : Academic Press, [2015]
©2015

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Location Call No. OPAC Message Status
 Axe Elsevier ScienceDirect Ebook  Electronic Book    ---  Available
Description 1 online resource : illustrations (some color)
text txt rdacontent
computer c rdamedia
online resource cr rdacarrier
text file
Bibliography Includes bibliographical references.
Note Online resource; title from PDF title page (EBSCO, viewed December 13, 2014).
Summary 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 companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS.
Contents 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 -- 1.6.1. Comments Concerning the Case Studies -- 1.7. Hints to enable you to understand the text -- 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 -- 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 -- 4. Conceptual Phase -- 4.1. 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 -- 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 -- 5.2.2.4. Validation and Verification -- 5.2.2.5. 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 -- 6. The Home Run -- 6.1. A summary of activity -- 6.2. The technical file -- 6.3. A note about manufacturing -- 6.4. A note about post market surveillance (PMS) -- 6.5. The final furlong -- 6.5.1. EU -- 6.5.2. FDA -- 6.6. Continual improvement.
Subject Medical instruments and apparatus -- Design and construction.
Analytical, Diagnostic and Therapeutic Techniques and Equipment
Investigative Techniques
Equipment Design
Equipment Design -- methods
Equipment and Supplies
TECHNOLOGY & ENGINEERING -- Technical & Manufacturing Industries & Trades.
Medical instruments and apparatus -- Design and construction
Genre/Form Case Reports
Case studies
Case studies.
Études de cas.
Added Title Class one devices
Case studies in medical devices design
Other Form: Print version: Ogrodnik, Peter J. Class 1 devices : case studies in medical devices design. London, [England] ; San Diego, California : Academic Press, ©2015 viii, 104 pages 9780128000281 (OCoLC)904423763
ISBN 9780128007969 (electronic bk.)
0128007966 (electronic bk.)
0128000287
9780128000281
9780128000281
Standard No. 9780128000281
AU@ 000053951278
AU@ 000056938608
CHBIS 010341580
CHBIS 010547578
CHNEW 001012621
CHVBK 33147686X
CHVBK 341786497
DEBBG BV042527233
DEBSZ 427902444
DEBSZ 482373229
GBVCP 817095667
NLGGC 401009548
NZ1 15874036

 
    
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