Medical device manuals are instructional materials designed to help users—including healthcare professionals, patients, and engineers—understand and safely operate devices used for diagnosis, treatment, monitoring, surgery, or rehabilitation.

These documents include information on product overview, components, specifications, installation, operating principles, usage instructions, warnings, maintenance, and troubleshooting. Since many devices are applied directly to the human body or used in life-support systems, accuracy and consistency in expression are essential.

Medical device translation requires interdisciplinary knowledge across medicine, pharmacy, mechanical engineering, electrical engineering, and IT/software. It is also necessary to consider document structure in accordance with the medical device certification requirements of each country such as CE (Europe), FDA (U.S.), and MFDS (Republic of Korea).

These translations are critical for product exports/imports, user training, product registration and overseas marketing. Their precision and completeness directly impact brand trust and regulatory approval.