Compiling all of the DHF documentation for a new medical device can be confusing, even for experienced engineers. That’s why I created this “map” of document interdependencies. It’s a way to help explain graphically how the many documents fit together for a new product. Some key points in the map are:
- Risk analysis drives many design requirements
- V&V testing depends on the release of many documents as well as hardware and software before it can begin
- Software documentation gets special scrutiny and needs to be carefully integrated with overall product documentation
- The 510(k) submission depends on completion of a broad set of DHF documents
This Documentation Map is based on a hypothetical medical device with hardware and software components, including sterile disposable components (i.e. a Class II interventional device with embedded software). The exact set of documents needed will vary across medical devices and quality systems, but will likely follow the outlines of this map if the device includes software.