We acquired a medical device design from another company and it came with a pretty complete design history for a specific intended use. We plan to use the same design for a different intended use with essentially no change. How can I best leverage the exisitng DHF without re-doing all the work. For example, can I treat the entire previous DHF as design input to my "new" device, and only update the risk analysis and design validation?

Thanks for your inputs.

Do you have your own list of input requirements? You could leverage the existing work when linking Outputs (what you have from the existing DHF) to Inputs.

Actually, I was thinking that the old DHF (including the design outputs from that) would be part of my new product's design INPUT. In addition, I will also need a new statement of intended use and requirements specific to that use. Then I can have an abbreviated design plan. Does that make sense?

It is probably just semantics. 'Inputs' where I am used to working are the requirements of your device, both external (customer requirements) and internal. You most likely have a list of things your device is required to do and you could easily link your existing DHF to these requirements w/out re-doing the work.

The way we would handle it is we would make a requirements document listing the requirement, acceptance criteria, source of the requirement, etc. Then we would have a results document that would link each requirement to the existing paperwork and you would be able to state 'xxx document from the prior DHF shows the device meets this requirement'. This would also show you where you have holes in your coverage.

Yes, creating a requirements document sounds like it would work perfectly for us. Really appreciate the "input"!