| Description |
1 online resource : illustrations (some color) |
| 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 |
| 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 |
| Bibliography |
Includes bibliographical references |
| Notes |
Online resource; title from PDF title page (EBSCO, viewed December 13, 2014) |
| Subject |
Medical instruments and apparatus -- Design and construction
|
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Analytical, Diagnostic and Therapeutic Techniques and Equipment
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Investigative Techniques
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Equipment Design
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Equipment Design -- methods
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Equipment and Supplies
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TECHNOLOGY & ENGINEERING -- Technical & Manufacturing Industries & Trades.
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Medical instruments and apparatus -- Design and construction
|
| Genre/Form |
Case studies
|
|
Case studies.
|
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Études de cas.
|
| Form |
Electronic book
|
| ISBN |
9780128007969 |
|
0128007966 |
|
0128000287 |
|
9780128000281 |
|
