Medical Device Design, Second Edition provides the bridge between engineering design and medical devices development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. It addresses medical devices regulatory (FDA and EU) requirements. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context, based on the authors' years of experience in academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the market place rapidly. This book is unique because it takes the reader through the process of medical device development from the very early stages of conceptualization all the way to commercialization on the global market, whilst being easy to read. This book stands out as a rare book that can be used by both professionals and newcomers to device design; it is written in straightforward and clear language and yet provides a vast amount of practical knowledge. References to standards and regulations are now updated. The regulations referenced in this book are ISO 13485:2016, FDA regulations and the European Medical Device RegulationNew case studies in the areas of: classifying medical devices, the design process, quality, labelling and instructions for use and moreAdditional content has been added around software and biocompatibility concerns INDICE: 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. Quality in Design 8. Design Realization/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. Postmarket Surveillance 14. Protecting Your IP 15. Obtaining Regulatory Approval to Market Appendix A. Useful Websites FDA Medical Devices Appendix B. Tables Appendix C. ISO 14971 Annex C Pre-Risk Analysis Questionnaire Appendix D. Generic Codes for Class I Medical Devices (MHRA) FDA Class I and II Exempt Devices Appendix E. Basic Materials Properties for Materials Selection E.1 Density E.2 Stress and Strain Appendix F.Standard Materials in Medicak Devices
- ISBN: 978-0-12-814962-1
- Editorial: Academic Press
- Encuadernacion: Rústica
- Páginas: 450
- Fecha Publicación: 01/09/2019
- Nº Volúmenes: 1
- Idioma: Inglés