Results for tag: "Design History File"

The Design History File (DHF) market is a subset of the medical device industry that focuses on the development and maintenance of records related to the design and manufacture of medical devices. DHF is a critical component of the medical device industry, as it provides a comprehensive record of the design, development, and manufacturing process of a device. This record is used to ensure that the device meets all applicable regulatory requirements and is safe for use. DHF also helps to ensure that the device is manufactured in accordance with the design specifications and that any changes to the design are properly documented. The DHF market is highly regulated, with stringent requirements for the documentation and maintenance of records. Companies in the DHF market must adhere to the regulations set forth by the relevant regulatory bodies, such as the US Food and Drug Administration (FDA). Some companies in the DHF market include Medtronic, Abbott, Johnson & Johnson, Stryker, and Becton Dickinson. Show Less Read more