Medical device documentation should give device users clear, accurate, and easy-to-follow instructions on how to set up, operate, maintain, and troubleshoot their devices. This chapter presents a human factors-based approach to designing documentation to achieve these goals and thereby promote the safe, reliable, and effective use of medical devices. Human factors principles for developing documentation are rst presented to lay the groundwork for the documentation design process. Two emerging trends in medical device use-the increasing prevalence of electronic documentation and use of medical devices by laypersons-are considered in terms of their implications for documentation design. An extensive set of design guidelines is provided that applies to both paper and electronic documentation, followed by guidelines that take into consideration the unique characteristics of electronic documentation. Case studies illustrate the value of the guidelines and demonstrate the bene ts of the user-centered approach advocated in this chapter. Finally, additional resources are provided for readers who desire to explore documentation design topics in more detail.