The safety of medical devices used in the diagnosis and treatment of diseases,
It can only be fully verified through scientific and systematic testing.

“Medical device” means an instrument, machine, device, material, software, or similar product used alone or in combination on humans or animals for the purpose of diagnosing, treating, alleviating, managing, or preventing disease, injury, or disability.

Medical device testing is a process for verifying the safety and effectiveness of medical devices by verifying that they meet national or international standards before being marketed in the relevant country. HCT provides product testing and certification services in accordance with national standards.

Accredited medical device testing institute

HCT is based on the ISO 17025 accreditation, which is the international standard for testing institutions.
As a testing laboratory designated by the Ministry of Food and Drug Safety and the U.S. FDA, we demonstrate world-class quality systems and technological prowess.

Ministry of Food and Drug Safety designated testing laboratory

US FDA ASCA certified testing laboratory

IECEE CBTL test

ISO 17025 A2LA Accredited Testing Laboratory

ISO 17025 KOLAS accredited testing laboratory

Testing Competency

Test area

01  

Electronic medical devices

WITH

02  

Software Medical Devices

SW

03  

Electromagnetic compatibility

EMC

04  

wireless communication

RF

05  

Environmental testing

Environment

06  

Cybersecurity

Cyber Security

Main test subjects
Product family

 

ultrasound

• Ultrasonic stimulator
• Focused ultrasound
• extracorporeal shock wave therapy

 

Optical/Laser

• 350nm ~ 12,000nm
• Laser surgery machine
• Light irradiator

 

Diagnosis and treatment

• ECG, EMG, PPG
• Patient monitoring device
• medicine injector
• High-frequency surgical machine
• low frequency stimulator

 

radiation

• Mammography equipment
• Devices for interventional surgery
• For dental and diagnostic use
• Computed Tomography

 

medical robots

• robotic surgical equipment
• Rehabilitation and correction robots
• Orthopedic exercise equipment
• Rehabilitation assistive devices

 

software

• Fully software
• web application
• Built-in software

Main Testing Services

Ministry of Food and Drug Safety Notice Exam

Safety and performance testing to verify compliance with approval and certification requirements for medical devices manufactured or imported for domestic sale.

MFDSMcivil service exam

Cyber Security

Overseas certification exam

IEC/EN 60601 & ISO 80601 Series related testing required for national certifications, including the US FDA and European CE.

FDA ASCACertification Exam

ISO 17025Certified Exam

CBCertified Exam

General Exam

Cyber Security

Quality Control Testing

Testing related to national projects, manufacturer quality control testing, pre-evaluation, etc.

General Exam

Examination registration and evaluation procedures

Step 1

Test registration and consultation

Step 2

Acceptance of contracts and submissions

Step 3

Review of documents and submissions

Step 4

Performing tests

Step 5

Issuance of test results