A Design History File (DHF) is part of a regulation that established new standards for medical devices. In the event of an audit by a regulatory body, you will need to provide information from the DHF. Medical design companies need to be prepared for the audits conducted by regulatory agencies such as FDA, and this means that they should understand the strengths and weaknesses of their DHF. I agree with srg36 that conducting internal audits is a good way to check if the DHF documents are updated. I must add that these internal audits should be able to bring to light the strengths and weaknesses of the DHF documents so that it becomes easy to meet the FDA’s requirement. In the company I worked for, there was always an internal audit of the DHF documents, and it was always carried out just before the FDA audit came to inspect the company. The aim is to ensure that ensure the DHF is audit-ready.