2025.03.05

‘AI Medical Device Development’ WALK101 Obtains MFDS GMP

WALK101 obtained GMP (Medical Device Manufacturing and Quality Control Standards) certification from the MFDS, establishing a quality management system that allows them to directly develop and produce software medical devices. The company plans to fully expand its AI SaMD lineup in the healthcare sector and technical commercialization in the future.

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WALK101 Co., Ltd. (CEO Dongsik Chae), a startup in the research and development business of artificial intelligence software medical devices, obtained GMP (Medical Device Manufacturing and Quality Control Standards) from the Ministry of Food and Drug Safety last December. GMP (Good Manufacturing Practice) is a quality management system standard managed by the Ministry of Food and Drug Safety, ensuring that medical devices produced by a medical device manufacturer are safe, effective, and consistently produced with quality suitable for their intended use. By obtaining GMP certification, WALK101 Co., Ltd. has qualified to produce software medical devices. In addition to the field of AI-based orthopedic imaging analysis software, it plans to produce AI solution software medical devices in the healthcare sector. CEO Dongsik Chae of WALK101 Co., Ltd. stated, "WALK101, which has taken the lead in technology development so that humanity can walk healthily up to the age of 100, plans to directly develop medical software and proceed with product approval through this GMP certification acquisition," and "We plan to further activate technical commercialization based on our current medical technology capabilities." Recognized for its technological prowess with the GMP certification acquisition, WALK101 Co., Ltd. is once again drawing attention by developing software that can easily measure bowlegs with a smartphone. This software, which can provide users with sufficient information by representing the degree of bowlegs in numerical angles, is based on technology that detects specific points necessary for angle measurement using artificial intelligence algorithms. It can evaluate various products such as leg correction insoles, bowleg correction bands, and bowleg correction exercise methods using the obtained information. CEO Dongsik Chae expressed his determination, stating, "If we utilize measurement software to recognize and prevent arthritis, a chronic degenerative disease, in advance, people will be able to walk well even in their elderly years, and their quality of life will also improve. We will dedicate ourselves to research and additionally develop AI medical devices that quickly and accurately judge large amounts of medical images in the future."