Design history file checklist

  • What documents are in a DHF?

    The DHF documentation must include identification of the design, methods of production, date, and individuals performing the validation.
    Design transfer: The process of transferring design into production, distribution, and installation specifications..

  • DHFs and audit readiness
    A DHF and fully documented procedures provide the FDA with the assurance that the device was developed properly and is safe for market.
    Note: Each device needs its own DHF and each DHF will be revised during any changes to the design.
What to Include in a Design History File
  1. Design and development plan.
  2. Design input, including user requirements specifications.
  3. Design output.
  4. Design review documentation.
  5. Design verification documentation.
  6. Design validation documentation.
  7. Design transfer.
  8. Design changes.
What to Include in a Design History File
  • Design and development plan.
  • Design input, including user requirements specifications.
  • Design output.
  • Design review documentation.
  • Design verification documentation.
  • Design validation documentation.
  • Design transfer.
  • Design changes.

What is DHF (design history file)?

What You Need To Know The DHF contains of references all the product development documentation created while designing your medical device

Learn how to structure your DHF perfectly and make your upcoming FDA audit a success

What should be included in a design history file?

Get our free checklist of the key elements to include in your design history file by clicking here

According to the FDA, “the design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part ( 21 CFR Part 820

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