Define the term "Design History File" (DHF).

The term "Design History File" (DHF) refers to a comprehensive collection of records that documents the design and development process of a medical device. This file is crucial for demonstrating compliance with regulatory requirements, as it captures all relevant information, including design specifications, design changes, verification and validation activities, and any safety or performance considerations throughout the device's lifecycle.

Having a well-documented DHF is vital for regulatory submissions, as it not only shows the development process followed but also provides evidence that the device meets quality standards and safety regulations. This historical documentation is beneficial for manufacturers to track changes and ensure that all elements of the design process are properly executed. The other options do not accurately capture the essence of what a DHF is; for instance, a database of marketed medical devices, standards for design engineers, or user manuals do not encompass the specific focus on the design and development records of a particular device.