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Business

Digital Medical Device

What is Digital Medical Device Testing?

FITI Testing & Research Institute supports domestic medical device companies entering the digital healthcare sector by facilitating public health promotion and chronic disease management. We support services focus on product commercialization, including test certification infrastructure, resolving technical challenges, and improving reliability. These efforts contribute to advancing the telemedicine industry.

Test Items

Target Key Test Items Representative standard
Electrical Safety
  • Common standard testing for electrical and mechanical safety.
  • Testing of electrical and mechanical safety for in vitro diagnostic analyzers according to common standards.
  • Individual standard testing for medical devices (in vitro diagnostics, u-healthcare, etc.).
  • Performance testing (including essential performance tests based on item characteristics).
IEC 60601-1
ISO80601-2-61
IEC 60529 etc.
Wireless communication suitability
  • Support for wireless communication essential requirements such as frequency deviation.
  • Testing and evaluation of parameters such as occupied frequency bandwidth, output, spurious emissions, and adjacent channel leakage power, supported in an integrated one-stop system.
SW functional safety
  • Support for the development lifecycle through static/dynamic software analysis.
  • Support for risk assessment, safety classification, and compliance verification according to the "Medical Device Software Approval and Review Guidelines."