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While medical advancement is accelerating worldwide, the importance of globalization of medical devices and medical device development systems is increasing.

Compared to other industries, the medical field has a more difficult certification process and acquisition. Among them, it is known that ISO 13485 certification can be obtained only 

when the conditions required by countries such as Europe and Canada, which have high standards, are met. For this reason, companies that have received the certification are evaluated as qualified to export medical devices to major countries around the world.

ISO 13485 certification is a standard established by the International Organization for Standardization (ISO), and is a certification system that verifies whether a company has a 

management system and quality management system that meets international requirements from medical device development to production. Companies and hospitals that have 

been certified for the stability of medical devices and are leading the globalization of domestic medical devices and development systems are receiving attention from the industry.

◆ Ingradient acquired ISO 13485 certification with medical data labeling technology.. "It will be the cornerstone for overseas expansion"

Artificial intelligence (AI) startup Ingradient (CEO Jun-ho Lee), which develops software specialized in 'interactive segmentation' and provides it to leading university hospitals and 

medical staff, obtained 'ISO 13485' in May.

This ISO 13485 acquisition means that Ingradient's technology has reached the level of medical device production and software quality management that conform to international 

standards. Not only has it established an environment where domestic medical researchers can conduct research easily and conveniently, but it is also the first step to contribute to 

the development of the global medical artificial intelligence industry.

In the process of developing the fastest semi-automatic medical image labeling software, Ingradient has developed its own 'MediLabel', a data preprocessing solution that can quickly and accurately process medical data needed for artificial intelligence learning, and supplies it to leading hospital researchers in Korea such as well as Asan Medical Center, Seoul St. Mary's Hospital, and Severance Hospital.MediLabel is drawing more attention as it can be used in all sectors that use medical image data regardless of the type of medical device, 

data format, or disease.

Jun-ho Lee, CEO of Ingradient, said, "We will use this certification as a stepping stone to present our Medilabel solution at the world's top Medical Image Computing and Computer-
Assisted Intervention (MICCAI) in September of this year." We will continue to create opportunities to promote our products to the world."

Meanwhile, Ingradient was selected for the 'Pan-ministerial Medical Device Standardization Project', which creates quality evaluation criteria for medical devices with big data and 

artificial intelligence technology applied last year, and has been named the first domestic company to create an international standard for medical data processing. 

◆ Korea University Guro Hospital's medical device test center obtained ISO 13485 certification for the first time in non-European countries

Korea University Guro Hospital's medical device usability test center obtained ISO 13485 certification as the first non-European international medical device quality management 

system implementation agency.

The service provided by the medical device usability test center at Korea University Guro Hospital has proven its high quality and stability. In the future, the center plans to make efforts to reflect usability throughout the medical device development process by providing medical device risk management services rather than simply performing tests.

Meanwhile, Korea University Guro Hospital's medical device usability test center has been designated as a 'medical device usability infrastructure establishment implementation 

agency' by the Ministry of Health and Welfare and the Korea Health Industry Development Institute. It is taking the lead in securing the stability of domestic medical devices and globalizing domestic medical devices by reducing errors in the use of medical devices, increasing user satisfaction, and conducting tests to identify additional risk factors.

◆ MedifarmSoft's portable heart disease self-diagnosis 'CardiI' certified ISO 13485

Medifarmsoft, an AI-based medical device platform company, has obtained ISO 13485 certification for 'CardiI', a portable heart disease self-monitoring device, and intelligent analysis reading software that analyzes measured vital signs.

Heart disease continues to rise as the leading cause of death worldwide and the second leading cause of death in Korea. Chest pain and the feeling of squeezing the chest are 

symptoms that require a visit to the hospital for examination, but they disappear after 5 to 10 minutes, so it is important to secure accurate data when symptoms appear.

In particular, by using MedifarmSoft's Cardi and intelligent analysis reading software, it is possible to efficiently manage diseases for both patients and medical staff through a remote monitoring service through a specialist's web viewer, so advanced medical settings can be expected. Driven by this momentum, MedifarmSoft is accelerating its entry into the global market by completing agent contracts with six countries in Asia, Africa, and the Middle East.

◆ Acquired ISO 13485 certification for Cerviray, the world's first AI-based cervical cancer solution

Cerviray, an AI solution for cervical cancer from AIDOT, a medical artificial intelligence company, also obtained ISO13485 certification.

Cerviray, developed by AIDOT, is the world's first artificial intelligence-based cervical cancer remote-reading AI system. It is equipped with CerviAID, an AI algorithm developed by 

AIDOT with its own technology, and the system was developed through joint research with Korea University Anam Hospital and obstetrics and gynecology department at Seoul 

National University Bundang Hospital.

AIDOT has signed contracts to enter several countries, including the Philippines, Uzbekistan, and Indonesia. In particular, Indonesia and the Philippines are made up of numerous 

islands, so there is a limit to smooth cervical cancer screening. Also, in Indonesia, cervical cancer ranks first among female cancer incidence rates, so the need for screening is high.

In this situation, AIDOT is expected to contribute to the eradication of cervical cancer by supplying Cerviray solutions to countries in need of cervical cancer screening. This is evaluated as a case in which domestic AI medical ICT solutions were recognized overseas and led to actual exports.

Ventursquare news / Reporter Hyo-jin Oh