I agree with the students who believe the DHF is a living document. If any change is made to the medical device, the information should be included in the DHF. If a certain part of the device is altered—such as a material change—then the change has to be looked at in terms of how it’s going to effect the entire product. Since the DHF is a compilation of records which described the design history of a finished device, it has to be closely assessed to determine whether or not the change had an impact on other aspects of the design. Additionally, the beauty of having a DHF is to have ONE document for companies to look back on, instead of flipping through multiple sets of documents. That being said, the DHF should be updated regularly as things within it change. Quality documentation is key to producing a successful medical device.