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This presentation will offer practical guidance in the UX engineering of medical devices with an emphasis on contrasting the objectives, methods, and documentation involved in formative versus summative usability testing. We will cite relevant FDA guidance, review some frequently used software tools, and show examples of typical deliverables. While our perspective is that of a consulting firm providing UX engineering services to medical device manufacturers, the material covered and guidance offered should be equally relevant to in-house UX teams. We will encourage the audience to raise corresponding points based on their own experience.