A practical approach to designing operating instructions for medical products in late or post-design phases.

@article{Gupta2009APA,
  title={A practical approach to designing operating instructions for medical products in late or post-design phases.},
  author={Suresh P Gupta and Melinda Lyons},
  journal={Journal of medical engineering & technology},
  year={2009},
  volume={33 3},
  pages={238-44}
}
User instructions, and especially operating instructions, are an essential part of the FDA's "medical device labeling" requirements and are intended to help ensure that the device is used safely and effectively. Their design should go hand-in-hand with the design of the product that they are going to accompany. However, for one reason or another, they are usually treated as something that can be tacked on at the end of the device development process. At this stage, it is often realized that… CONTINUE READING