[Edaily Reporter Shin Ha-yeon] #NeuroMeka, a company specializing in collaborative robots and physical AI, has laid the groundwork for expanding its medical robotics business by obtaining Good Manufacturing Practice (GMP) certification.

NeuroMeka announced on the 5th that it has passed the initial inspection for the Ministry of Food and Drug Safety’s Good Manufacturing Practice (GMP) for medical devices and received certification of compliance.

This certification was obtained following an audit by the Korea Testing Laboratory (KTL), which was delegated the review by the Ministry of Food and Drug Safety. The certified product is a Class II medical device, the “Universal Electric Medical Clamp,” and the certification is valid for three years.

GMP is a quality management system that oversees the entire production process of medical devices, including design, manufacturing, inspection, quality assurance, and traceability. Since medical devices are used directly on the human body, they require a higher level of quality control standards than general industrial products.

NeuroMeka explained that this certification officially recognizes that the quality management system at the facility complies with medical device standards.

The company already possesses experience in manufacturing robots for the medical field. In 2023, it signed a supply contract with Qurex, a medical robotics specialist, to provide robotic arms for artificial joint surgery robots, thereby accumulating manufacturing capabilities on par with medical device standards.

Furthermore, the company is expanding its medical business based on its in-house capabilities to develop and produce not only collaborative robots, autonomous mobile robots (AMRs), and delta robots, but also core components such as actuators, controllers, and motors.

NeuroMeka is currently conducting field trials of a neurosurgical endoscopic surgical assistance robot through the Korea Institute for Robot Industry Promotion’s Regulatory Innovation Demonstration Project. The company is also participating in the Ministry of Health and Welfare’s ARPA-H project to develop medical assistance humanoids and AI-based surgical assistance robots.

The company expects this GMP certification to serve as a crucial foundation for the future commercialization of medical robots.

A NeuroMeka official stated, “GMP is a system that evaluates not only the product itself but also the overall quality management system of the manufacturing facility,” adding, “Through this certification, we have confirmed that our robot manufacturing quality capabilities meet the standards of the medical device sector.”

They added, “We plan to continue strengthening our quality competitiveness across various robot product lines that require high reliability, including those in the medical field.”