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Author:   Peter J. Ogrodnik (Partner in Metaphysis LLP, Award Leader MSc Medical Engneering Design at Keele University, Honorary Professor Guangxi University of Science and Technology)
Publisher:   Elsevier Science Publishing Co Inc
Imprint:   Academic Press Inc
Edition:   2nd edition
Weight:   0.880kg
ISBN:  

9780128149621

ISBN 10:   0128149620
Pages:   538
Publication Date:   26 October 2019
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   Manufactured on demand  
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Table of Contents

1. Introduction 2. Classifying Medical Devices 3. The Design Process 4. Implementing Design Procedures 5. Developing Your Product Design Specification 6. Generating Ideas and Concepts 7. Enhancing Quality in Design 8. Design Realisation/Detailed Design 9. Risk Management, Risk Analysis and ISO 14971 10. Evaluation (Validation and Verification) 11. Manufacturing Supply Chain 12. Labelling and Instructions for Use 13. Post Market Surveillance 14. Protecting Your IP 15. Obtaining Regulatory Approval to Market Appendix A. Useful Websites Appendix B. Tables Appendix C. ISO 14971 Annex C Pre–Risk Analysis Questionnaire Appendix D. Generic Codes for Class I Medical Devices (MHRA) Appendix E. Basic Materials Properties for Materials Selection Appendix F. Standard Materials in Medicak Devices

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Author Information

Professor Ogrodnik is a Chartered Mechanical Engineer, a Member of the Institution of Engineering Designers and a Fellow (regional) of the Royal Society of Medicine, an Honorary Consultant at the Royal Stoke University Hospital. For over 20 years he has conducted research into optimising the treatment of tibial fractures. Using this research base he has enhanced the application of engineering design principles to the solution of medical devices, his book Medical Devices Design is a core text in core R&D departments. He has founded two medical devices companies (one manufactures and sells medical devices to the NHS and beyond) and is named inventor on numerous patents. He was a founding director of the University spinout Intelligent Orthopaedics Ltd, and is a founding partner of Metaphysis LLP. Through this corporate involvement Professor Ogrodnik has an understanding of the realities of applied research for industry; for example he was a member of the AWM Healthcare Technologies cluster opportunity group.

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