Design History File content

Design History File content

The design history file (DHF) is a very important document for a medical device, because it is what may be called the route map for the product’s design. It is proof that the device followed the right method on the way to arriving as the final product.

What is DHF?

It is defined, rather broadly, in ISO 13485 as being the record needed to provide evidence that the realization processes and the resulting product meet their specified requirements. 21 CFR 820.3 (e) of the FDA also describes DHF broadly as a compilation of records which describe the design history of the finished medical device.

Design history file content

Design history file content is described by both the FDA and ISO 13485.

Design history file content according to the FDA

  • General: A few Class I, Class II and Class III devices are listed here. These are the devices for which design controls apply
  • Design and development planning
  • Design input
  • Design output
  • Design review
  • Design verification
  • Design validation
  • Design transfer
  • Design changes
  • Design history file

ISO 13485

According to ISO 13485, design history file content should consist of the following rules:

  • The manufacturer shall establish plans thatdescribe the design and development activities
  • The plans shall identify and describe theinterfaces with different groups or activities thatprovide input to the design and developmentprocess
  • The plans shall be reviewed, updated and, andapproved as design evolves

References:

http://www.ece.mcmaster.ca/~patriciu/QSR.pdf

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=820.30

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