Design history file template

  • What are the requirements for DHF?

    There are two key terms in the DHF requirement: “establish” and “maintain.” “Establish” means that the development team must define, document, and implement requirements.
    Evidence is found in procedures, work instructions, drawings, and other similar documents..

  • What is the purpose of the DHF?

    The Design History File (DHF): is a collection of documents that describe the design and development activities of a medical device.
    Its purpose is to demonstrate that the device was developed using the design control process needed to meet FDA requirements..

  • What should be in a DHF?

    What belongs in your DHF? Your DHF should contain all of the documentation created during the product development phase of your medical device.
    Following the mandated design controls process closely will help you understand what documents are required, as each step generates its own documentation..


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