Medical device manufacturers must understand the importance of a traceability matrix as defined by ISO 13485:2016 under Design Control traceability. The Requirements Traceability Matrix is an excellent internal tool for project management that ensures that the team has access to design history and ensures nothing is left undeveloped during the Design Control process. The medical device manufacturer can use RTM to view the entire design history, including evidence of quality controls to ensure that the design goals are duly met.