본문 바로가기

Business

Digital Medical Device

What is Digital Medical Device Testing?

Digital medical device testing supports domestic medical device companies in entering the digital healthcare market to promote public health and chronic disease management. It provides product-focused services, including certification infrastructure, technical troubleshooting, and reliability enhancement, contributing to the growth of the telemedicine industry.

Test Items

Category Key Test Items Representative standard
Electrical Safety
  • Common standard tests for electrical/mechanical safety
  • Testing of electrical and mechanical safety for in vitro diagnostic analyzers according to common standards
  • Device-specific standard testing (in vitro diagnostics, u-healthcare, etc.)
  • Performance testing (essential performance tests based on item characteristics)
 IEC 60601-1
ISO80601-2-61
IEC 60529 etc.
Wireless Communication Compliance
  • Support for essential requirements (e.g., frequency tolerance)
  • Testing of occupied bandwidth, output, spurious emissions, adjacent channel leakage
Software Functional Safety
  • Static/dynamic software analysis
  • Risk assessment and safety classification according to the "Medical Device Software Approval and Review Guidelines"