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Technical Support
Support on evaluation test for stability, performance, physical property, and reliability for medical device
Safety evaluation for electronic medical device
Electrical / Mechanical safety evaluation for medical device in accordance with IEC 60601-1
Review on risk management in accordance with ISO 14971
Property evaluation on implant medical device
Mechanical property evaluation on medical device in accordance with international standards such as ISO/ASTM
Performance evaluation on electronic medical device
Standard specification and essential performance test evaluation for medical device in accordance with IEC 60601-2-xx
Test evaluation according to manufacturer specification of 9 product groups specified by the Ministry of Food and Drug Safety
Environment and reliability evaluation
Vibration, falling, and shock evaluation
Test evaluation for temperature and humidity / thermal shock
Test evaluation for water-proof / dust-proof performance
Support on test evaluation for electromagnetic conformity (EMC)
Test for electromagnetic
wave on electronic medical device
IEC 60601-2
FDA common standard specification
Test for electromagnetic wave on electronic medical device in accordance with EN 60601-1-2
Risk management support on electromagnetic wave
KOLAS
Certificate
National defence (ML-STD 461 series)
Medical device (CISPR 11, etc.)
ICT device (CISPR 32, etc.)
General device (EC 61000-6 series)
General electromagnetic
wave test
EN 55011
EN 55032
EN 61000-6-1, 2, 3, 4
Support on European DoC certificate such as EN 61000-4 series
De-bugging support
Another
task
R&D support on medical device
Support on training for electromagnetic wave
Electrical·Mechanical safety and performance test
Withstanding voltage tester
Oscilloscope for safety evaluation
Leak current measuring device
Ultrasonic wave measuring device
Test Corner
Integrating Sphere
Internal defibrillator
Digital Manometer
Support on mechanical property test for medical device in accordance with ISO/ASTM
３kN universal testing machine
Universal tester
Universal tension testing machine
Support on reliability test in a different environment
Vibration tester
Falling tester
Shock tester
Temperature & Humidity chamber
Thermal shock tester
Dust tester
Impulse insulation testing device
- 77, Soro 2-gil, Oksan-myeon, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do
- Business registration number : 369-81-01571
- CEO : Lee Hak-sung
- TEL +82-70-8015-1770
- E-Mail titopeng12@gmail.com
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