Design History File (DHF) Compilation for Medical Devices
As part of the Safe Medical Device Act in 1990, the FDA mandated the Design History File (DHF), which contains all the development documentation pertaining to a medical device/product/diagnostic, which is generated by the design control process. Preparing a DHF as per the Regulatory requirements and withstanding the Regulatory Agencies’ scrutiny is a key challenge for all the medical devices manufactures and developers.