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    Database is a collection of data stored in a computer disc space or server space.


    Validating application design against specifications

    One of the main objectives of the CDRH is “setting and enforcing good manufacturing practice regulations and performance standards for medical devices”. National Instruments has taken years of experience in this field and applied it to delivering tools directly targeting at easing the compliance to these and other industry regulations.The document reserved for regulations put forth by the FDA is called the Code of Federal Regulations Title 21 (21 CFR), and the two sections that lay out regulations regarding the design, development, test, and manufacturing of a medical devices are Section 11 (21 CFR Part 11) and Section 820 (21 CFR Part 820). Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation.There are controls for different types of validation, such as range checking or pattern matching. Each validation control references an input control (a server control) elsewhere on the page.

    Validation controls provide an easy-to-use mechanism for all common types of standard validation—for example, testing for valid dates or values within a range—plus ways to provide custom-written validation.In this tutorial, we will focus on Section C of 21 CFR Part 820, or the design controls necessary to comply. National Instruments provides a complete graphical system design platform that allows you to design and manage code throughout the development process. In the diagram above , you can see the various add on modules, toolkits, and complementary products that are specifically designed for their respective phase of device design.(1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. We will see concrete examples of these through this document.(2) The following class I devices are subject to design controls: (i) Devices automated with computer software; and (ii) The devices listed in the following chart. For more in depth resources on the software engineering process, visit ni.com/largeapps.----------------------------------------------------------------------------------------------------------- Section Device ----------------------------------------------------------------------------------------------------------- 868.6810.......................... Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient.

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