As healthcare becomes increasingly advanced worldwide, the importance of the globalization of medical devices and medical device development systems is growing even further.
Compared to other industries, the medical sector generally faces stricter and more difficult certification procedures. Among them, ISO 13485 certification is widely known to require meeting conditions demanded by countries with high standards, such as Europe and Canada. For this reason, companies that obtain this certification are regarded as having the qualifications to export medical devices to major countries around the world.
ISO 13485 is a standard established by the International Organization for Standardization (ISO). It is a certification system that determines whether an organization has a management system and quality management system that meet international requirements from medical device development through production. Companies and hospitals that have certified the safety of medical devices and are taking the lead in the globalization of domestic medical devices and development systems are drawing attention in the industry.
◆ Ingredient obtains ISO 13485 certification with medical data labeling technology: “A cornerstone for overseas expansion”
Ingredient (CEO Lee Jun-ho), an AI startup that develops software specialized in interactive segmentation and provides it to major university hospitals and medical professionals, obtained ISO 13485 in May.
This ISO 13485 acquisition signifies that Ingredient’s technology has reached an internationally standardized level of medical device production and software quality management. It is seen as not only establishing an environment in which domestic medical researchers can conduct research more easily and conveniently, but also as the company’s first step toward contributing to the development of the global medical AI industry.
Ingredient, which is working to realize the development of what it describes as the fastest semi-automated medical image labeling software available, has developed its own data preprocessing solution, “MediLabel,” which can process medical data needed for AI learning quickly and accurately. It supplies MediLabel to research teams at major hospitals in Korea, including Asan Medical Center, Seoul St. Mary’s Hospital, and Severance Hospital. MediLabel is drawing attention because it can be used across all specialties that utilize medical imaging data, regardless of device type, data format, or disease type.
CEO Lee Jun-ho said, “Building on this certification, we plan to present the MediLabel solution in September at the world’s leading medical imaging conference, MICCAI (Medical Image Computing and Computer-Assisted Intervention),” adding, “We will also accelerate preparations for overseas expansion and continue creating opportunities to introduce our products worldwide.”
Meanwhile, Ingredient was selected last year for the pan-ministerial medical device standardization project, which establishes quality evaluation standards for medical devices incorporating big data and AI technologies, and it was recognized as the first domestic company to set an international standard for medical data processing.
◆ Korea University Guro Hospital Medical Device Usability Test Center becomes the first outside Europe to obtain ISO 13485 certification
The Medical Device Usability Test Center at Korea University Guro Hospital obtained ISO 13485 certification as the first non-European institution to be certified as an implementing body for an international medical device quality management system.
This certification demonstrates the high quality and safety of the services provided by the center. Going forward, the center plans to move beyond being an organization that simply performs tests and instead provide medical device risk management services, working to ensure that usability is reflected across the entire medical device development process.
Meanwhile, the Korea University Guro Hospital Medical Device Usability Test Center has been designated by the Ministry of Health and Welfare and the Korea Health Industry Development Institute (KHIDI) as an implementing institution for the medical device usability infrastructure 구축 initiative. By conducting tests that reduce usage errors, increase user satisfaction, and identify additional risk factors, the center is helping secure the safety of domestic medical devices and leading efforts to globalize Korea’s medical device industry.
◆ MediphamSoft’s portable self-check heart disease device “CardiI” receives ISO 13485 certification
MediphamSoft, an AI-based medical device platform company, obtained ISO 13485 certification for its portable heart disease self-measurement device, “CardiI,” and for its intelligent analysis and interpretation software that analyzes the measured biosignals.
Heart disease is the leading cause of death worldwide and ranks second in Korea, and it continues to increase. Symptoms such as chest pain or a squeezing sensation in the chest require hospital testing when they occur, but they often disappear after 5–10 minutes, making it especially important to secure accurate data at the time symptoms appear.
In particular, by using MediphamSoft’s CardiI and its intelligent analysis and interpretation software, both patients and medical staff can manage conditions more efficiently through a remote monitoring service via a specialist web viewer—raising expectations for more advanced medical practice. Building on this momentum, MediphamSoft is accelerating its global expansion, including completing agent agreements with six countries across Asia, Africa, and the Middle East.
◆ World’s first AI-based cervical cancer solution “Cerviray” obtains ISO 13485 certification
AIDOT’s AI cervical cancer solution “Cerviray” has also obtained ISO 13485 certification.
Developed by AIDOT, Cerviray is described as the world’s first AI-based remote interpretation system for cervical cancer. It is equipped with AIDOT-NETv1, an AI algorithm developed with AIDOT’s proprietary technology, and the system was developed through joint research with the obstetrics and gynecology departments of Korea University Anam Hospital and Seoul National University Bundang Hospital.
AIDOT has signed expansion agreements with multiple countries, including the Philippines, Uzbekistan, and Indonesia. In particular, Indonesia and the Philippines are made up of numerous islands, which creates limitations for smoothly conducting cervical cancer screening. In Indonesia especially, cervical cancer ranks first in incidence among women’s cancers, making the need for screening particularly high.
Against this backdrop, it is expected that by supplying the Cerviray solution to countries where cervical cancer screening is needed, AIDOT can contribute to the fight against cervical cancer. This is also assessed as a case in which a domestic AI medical ICT solution was recognized overseas and led to actual exports.
Published: July 6, 2022 / VentureSquare / Reporter Oh Hyo-jin
