Design History File

Overview

A Design History File (DHF) is a document that describes the design history of a finished Medical Device. The DHF is a part of regulation introduced in 1990, when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for Medical Devices that can cause or contribute to the death, serious illness, or injury of a patient. It is necessary to focus on two aspects of the definition:

• Defining which records comprise the DHF
• Focus on the Start and End Points of DHF

Most of the Regulatory agencies have not specifically provided the exact document content requirements, but following are the high-level contents of a DHF, which are generally accepted by the agency reviewers or auditors along with other required elements:

• Design plan
• User needs
• Design inputs
• Design outputs
• Risk analysis, including hazard identification
• Human factors analysis
• Design verification, with acceptance criteria
• Design validation, with acceptance criteria
• Design changes
• Software validation—if applicable
• Design reviews
• Design transfer

Freyr makes it easier to compile your DHF or carry out DHF remediation, as per the requirements of target health agencies, like, the US FDA (21 CFR Part 820) or ISO certified notified bodies. The DHF regulations allow Medical Device companies to present their DHF as a document that references the product development documentation for your Medical Device.

Key Interpretations of the DHF Guidance Include:

• A DHF must be maintained for each type of device manufactured by the company. If there are similar versions of the same device with similar design, its recommended to include all the data in a single DHF
• A DHF is critical to demonstrate that the device was developed in accordance with both the design plan and the requirements. In the whole process, design plan must reflect compliance and it is an important part of the DHF. It must either contain or refer to the necessary documents from where the information is sourced. This means that you could either create a folder that contains the required documents or create a document that acts as a reference sheet for the required materials.