Description

Book Synopsis


Table of Contents
1. Introduction2. Classifying Medical Devices3. The Design Process4. Implementing Design Procedures5. Developing Your Product Design Specification6. Generating Ideas and Concepts7. Enhancing Quality in Design8. Design Realisation/Detailed Design9. Risk Management, Risk Analysis and ISO 1497110. Evaluation (Validation and Verification)11. Manufacturing Supply Chain12. Labelling and Instructions for Use13. Post Market Surveillance14. Protecting Your IP15. Obtaining Regulatory Approval to Market Appendix A. Useful WebsitesAppendix B. TablesAppendix C. ISO 14971 Annex C Pre–Risk Analysis QuestionnaireAppendix D. Generic Codes for Class I Medical Devices (MHRA)Appendix E. Basic Materials Properties for Materials SelectionAppendix F. Standard Materials in Medicak Devices

Medical Device Design

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    A Paperback by Peter J. Ogrodnik

    £999.99

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      Book details

      Publisher Academic Press Inc
      Published 10/26/2019 12:00:00 AM
      ISBN-13 9780128149621
      978-0128149621
      ISBN-10 0128149620
      Also in:
      Biomedical engineering / Medical engineering

      Description

      Book Synopsis


      Table of Contents
      1. Introduction2. Classifying Medical Devices3. The Design Process4. Implementing Design Procedures5. Developing Your Product Design Specification6. Generating Ideas and Concepts7. Enhancing Quality in Design8. Design Realisation/Detailed Design9. Risk Management, Risk Analysis and ISO 1497110. Evaluation (Validation and Verification)11. Manufacturing Supply Chain12. Labelling and Instructions for Use13. Post Market Surveillance14. Protecting Your IP15. Obtaining Regulatory Approval to Market Appendix A. Useful WebsitesAppendix B. TablesAppendix C. ISO 14971 Annex C Pre–Risk Analysis QuestionnaireAppendix D. Generic Codes for Class I Medical Devices (MHRA)Appendix E. Basic Materials Properties for Materials SelectionAppendix F. Standard Materials in Medicak Devices

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