Design history file (DHF)

A design history file (DHF) is a document that keeps track of all the design elements of a medical device and how they have evolved during the product development stage. It is a mandatory document for medical device manufacturers. 

In addition, it defines the user requirements and how the product will fit the end users' needs best. The design history file contains several documents defining user needs, the design input, the design process, or the design output. 

How does structured content authoring help? 

Structured content authoring can help improve the traceability of the DHF and help the process and document owner know at any point in time who made what changes, where, and when. 

Creating and maintaining the DHF with a structured content authoring tool helps reduce time-to-market and enhance regulatory compliance across all the departments involved in creating the document.

Key benefits

  • Use templates to ensure regulatory compliance in a certain geography or market 
  • Integrate translation management and create documents that are available in multiple languages faster 
  • Reuse modular content in different areas of your file by defining a single source of truth

Related terms

Related content