Have you ever been developing a product and lost your requirements in an Excel based trace matrix even though you thought it was well organized and clear? Despite a complete Excel trace matrix, you seem to lose your requirements in the jumble of thousands. You look for a requirement that you know shows up 10 times in the matrix, but as you browse through them to find it, you notice there are four different versions of the same requirement. You could have sworn the last time you updated the trace matrix you hit all of the duplicates—you checked and double-checked, but, alas, the “same” requirement written four slightly different ways has made it through your review process. Your organization gets ready to submit a complete product design package, such as a 510(k), which includes multiple deliverables or “artifacts.” Some of these deliverables include trace matrix reports showing the interconnection of requirements and tests to ensure all requirements have been validated. Part of your process is to verify the traceability of your requirements, risks, and tests is intact. You noticed there are several requirements that are not identical, but they have the same ID and their intent was the same. The requirements are theoretically trying to meet the same end goal, but you are stuck with partial repetition, wasted time, erroneous traceability, and possible compliance issues.