Which of the following is essential when preparing a Design History File (DHF)?

The Design History File (DHF) is a critical component required by regulatory authorities, particularly the FDA for medical devices. It serves as a comprehensive collection of documents that provide clear evidence of the design and development process of a medical device. The core purpose of the DHF is to demonstrate that a device has been developed in accordance with established design control requirements, ensuring compliance with relevant regulations.

Documentation supporting the design and development of the medical device is essential because it includes all relevant design planning, design inputs, design outputs, design verification and validation, and changes made throughout the development process. This documentation helps to ensure that the medical device is safe and effective, reflecting that due diligence was applied during its creation. It is also vital during regulatory reviews and inspections.

In contrast, while marketing materials may contribute to the understanding of a product's intended use, they do not provide the technical details necessary for demonstrating compliance with design control requirements. User manuals, though important for providing guidance to consumers, are not part of the design and development documentation per se. Financial performance reports are generally irrelevant to the DHF, as they do not pertain to the technical or regulatory aspects of the device's design and development process. Thus, the core requirement for the DHF revolves around