1st Edition

Handbook of Medical Device Design

Edited By Richard C. Fries Copyright 2001
    792 Pages
    by CRC Press

    792 Pages
    by CRC Press

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    First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

    Section 1: Standards and Regulations

    1. FDA Regulations

    Richard C. Fries

    2. Preparing an FDA Submission

    Richard C. Fries

    3. European Standards and Regulations

    Richard C. Fries

    4. The Medical Device Directives

    Richard C. Fries

    5. The Basis of ISO 9001

    Tina Juneau

    6. Design of Medical Devices for the Canadian Market

    Paul Fabry

    7. Pacific Rim Standards and Regulations

    Richard C. Fries

    8. Overview of Software Standards

    Nancy George

    Section 2: Determining and Documenting Requirements

    9. Defining the Device

    Richard C. Fries

    10. Documenting Product Requirements

    Richard C. Fries

    11. Medical Device Records

    Richard C. Fries

    Section 3: The Design Phase

    12. Hazard and Risk Analysis

    Markus Weber

    13. Hardware Design

    Richard C. Fries

    14. Software Design

    Sherman Eagles

    15. Human Factors Engineering

    Richard C. Fries

    16. Biocompatibility

    Richard C. Fries

    17. Reliability Assurance

    Richard C. Fries

    18. Product User Guides

    Margaret Rickard

    19. Translation: "It’s a Small World After All"

    Margaret Rickard

    20. Liability

    Richard C. Fries

    21. Intellectual Property

    Richard C. Fries

    Section 4: Verification and Validation

    22. Testing

    Lisa Henn

    23. Overview of Verification and Validation for Embedded Software in Medical Systems

    Andre Bloesch

    24. Software Verification and Validation

    Sherman Eagles

    25. Reliability Evaluation

    Richard C. Fries

    26. Analysis of Test Results

    Richard C. Fries

    Section 5: The Manufacturing/Field Phase

    27. Quality System Regulation and Manufacturing

    Richard C. Fries

    28. Configuration Management

    Richard C. Fries

    29. The Quality System Audit

    Tina Juneau

    30. Analysis of Field Data

    Richard C. Fries

    Biography

    Richard C. Fries is Manager of Reliability Engineering, Datex-Ohmeda, Inc., Madison, Wisconsin.

    "a worthwhile reference and source. . ..Biomedical and engineering libraries would benefit from this addition to their reference collections."
    ---E-Streams