Service area
Complete and Comprehensive Service in Testing

Medical Equipment and Medical Electronic Equipment


Medical devices, medical electronic equipment and in-vitro diagnostic equipment

Surgical lights, multi-functional patient monitors, non-invasive electronic blood pressure monitors, blood glucose self-monitoring systems, medical nebulisers, medical electrical equipment and systems for home use, neuromuscular stimulators, electric surgical tables, electric hospital beds, infusion pumps and controls, medical oximeters, medical electric blankets/pads/beds, medical electrical suction equipment - electric sputum extractors, in-vitro diagnostic medical equipment, etc. Electric hospital beds, surgical lights, respiratory Humidifier, Potentiostat, Medical Heater, Endoscope Cleaner & Steriliser, Portable Colour Ultrasound, Blood Glucose Meter, Magnetic Resonance Induced High Intensity Focused Ultrasound Therapy System, Focused Ultrasound for Therapy, Laboratory Equipment, In-vitro Diagnostic Equipment, Large Sterilizer, etc.

Test Service

Safety Test Service

  • Taiwan:CNS 14509-1、CNS 15521
  • International:IEC 60601series、IEC 80601-2-30、ISO 80601-2-56、 ISO 9919、ISO 80601-2-61、ISO 10079-1
  • Europe:EN 60601series、EN 80601-2-30、EN 1060-1、EN 1060-3、EN 13544-1

EMC Test Service

  • International:IEC 60601-1-2+A1、IEC 61326-1/-2-6、CISPR 11
  • Europe:EN 60601-1-2、EN 61326-1、Regulation-EU- 2017/745、Regulation-EU-2017-746
  • China:GB/T 18268.1/.26、YY 0505

Software Test and Calibration Service

Reliability Test Service

Certification Services

GMP/QSD and CB report of Ministry of Health and Welfare

Professional Service
  • Product Validation Consultation (TFDA, FDA, EU Medical Device MDD/MDR, EU In Vitro Diagnostic Medical Device IVDD/IVDR)
  • Medical device product development planning
  • Risk Management Report Planning
  • Accessibility Assessment Report Planning
  • Inspection and Registration Services