The core purpose of the Design History File is to outline all the steps involved in the development of the Medical device. What is a Design History File (DHF)?Ī design history file is a set of organized documents that clearly outline the evolution of the design from the initial stage to the final stage. Here we keep our focus only on DHF, Design History File. FDA, the supreme authority auditing and approving a device for market release demands all steps and processes to be documented from scratch.Īlthough, there are many crucial documentation requirements such as DMR (Device Master Record), DHR (Device History Record) & DHF (Design History File).
Not only it is a necessary practice for end-user’s safety but also equally necessary for the developer & manufacturer. Each step needs strict monitoring and documentation.īut why document everything? Is it just because Medical Devices deal with human lives? Medical Device Development is a multilevel process.