We work with outside companies that design/develop our commercial medical devices. So I indirectly come into contact with DHFs, but don’t have an influence on the practices of the company we contract to develop the device. I personally however think the school of thought that says the DHF is a living document is most appealing to me, because I think if changes are made (even if they are small) they should be captured in the DHF. I think having a central electronic document to go back and see the changes is essential and would be good in case the FDA came in for an audit because it would be an accurate representation of the product you are delivering to the consumer on the market.