What is the purpose of a Design History File (DHF) in medical device development?

• A. To document the production batch records for manufacturing.
• B. To store user manuals.
• C. To document the design process, decisions, verifications, and validations showing how the device meets requirements through development.
• D. To plan marketing campaigns.

Answer: (C)

The Design History File is where the entire design process is documented to show how the device evolves from concept to final design and how it meets all requirements through development. It includes records of design inputs and outputs, design reviews, verification and validation activities, risk management, and any design changes, tying every step back to the requirements. This collection provides traceability from what was needed to what was created, and demonstrates that design controls were followed and the device is capable of meeting its intended use.

This isn’t about production batch records, user manuals, or marketing plans. Those belong in other files or documentation areas. The DHF focuses specifically on the design side—proving, with evidence, that the device was designed properly and validated to meet the specified needs.