Class 1 Devices Case Studies in Medical Devices Design 1st Edition by Peter J Ogrodnik ISBN 0128000287 9780128000281

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Product details:

ISBN 10: 0128000287 

ISBN 13: 9780128000281

Author: Peter J. Ogrodnik

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.

Table of contents:

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
1.7 Hints to enable you to understand the text

Chapter 2: Classification
2.1 Introduction
2.2 FDA classification
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

Chapter 4: Conceptual Phase
4.1 A reminder about space
4.2 The relationship with your product design specification (PDS)
4.3 Solution selection
4.4 Summary

Chapter 5: Embodiment Phase
5.1 A reminder about this phase
5.2 Initial embodiment – or first prototype phase
5.3 Prototype to final design
5.4 Summary

Chapter 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
6.6 Continual improvement

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Tags: Peter J Ogrodnik, Class 1 Devices, Medical Devices, Design, Case Studies, Engineering, Healthcare