Class 1 Devices - 1st Edition - ISBN: 9780128000281, 9780128007969

Class 1 Devices

1st Edition

Case Studies in Medical Devices Design

Authors: Peter Ogrodnik
eBook ISBN: 9780128007969
Paperback ISBN: 9780128000281
Imprint: Academic Press
Published Date: 25th November 2014
Page Count: 114
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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 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.

Key Features

  • These titles will assist anyone who is working in the medical devices industry or who is studying biomedical subject areas to design a successful medical device and avoid repeating past mistakes.
  • Written by an experienced medical device engineer and entrepreneur, with real world experience of developing and commercializing medical products.
  • Joins up theory and practice in an accessible style.


Medical and Biomedical Engineers, plus medical and clinical professionals involved with medical device design.

Table of Contents

  • Dedication
  • Acknowledgements
  • Chapter 1: Introduction
    • Abstract
    • 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
    • Abstract
    • 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
    • Abstract
    • 3.1. Introduction
    • 3.2. Developing the specification
  • Chapter 4: Conceptual Phase
    • Abstract
    • 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
    • Abstract
    • 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
    • Abstract
    • 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 furlong5
    • 6.6. Continual improvement
  • References
  • Annexure I: Essential Requirements


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© Academic Press 2015
Academic Press
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About the Author

Peter Ogrodnik

Affiliations and Expertise

Professor of Engineering Design at Staffordshire University (UK) and co-founder of Intelligent Orthopaedics Ltd.

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