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Software User Requirements Specification Form
Form used to define and document the user needs of the medical device software system based on the intended use and indications for use of the device, including the requirements for proper operation and intended clinical outcomes of the software.

Software User Requirements Specification Form

$95.00Price

  • Microsoft Word File  (5 pages total)

    1. Purpose
    2. Scope
    3. Responsibilities
      1. Project Manager
      2. Quality Engineering
      3. Software Development
    4. References
    5. Definitions
    6. User Requirements Specification
      1. Intended Use and Indications for Use
      2. User Characteristics
      3. User Requirements
    7. Revision History
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