October 26, Seoul, Korea - Smart rehabilitation solution startup, NEOFECT announced on Oct. 26th that they received the ISO 13485 certificate (Quality Management System for the design and manufacture of medical devices) and the CE mark.
NEOFECT builds an international standard quality management system providing a consistent service by eliminating any problems of damage or deterioration in all processes regarding production, storage and delivery of medical devices through receiving the ISO 13485 certificate.
After registering their smart glove RAPAEL on the MFDS in Korea and the US FDA in August 12th 2014, NEOFECT will expand their footprint in the healthcare market by receiving the ISO 13485 and the CE mark.
RAPAEL smart glove is a medical device allowing stroke patients to play games for rehab exercises that are designed to help the rehabilitation of the fingers, wrist and forearm. The games that are provided with the product are designed to stimulate both the visual and auditory senses. This increases the brain plasticity as well as muscle retention.
With the accumulated data from the task oriented training, ‘Rehabilitation training algorithm’ analyzes the data and then provides task-training games that suit the patient by adjusting the training level during the games to provide appropriate goals and increasing motivation.
“With this ISO 13485 and the CE mark, NEOFECT’s smart rehabilitation technology has been recognized in the tough European Market” said CEO Ho Young Ban, “NEOFECT targets not just the Korean market but to expand to the international market. We recently opened a US branch and are in the process of opening a European branch. These certifications will aide our expansion into the EU market.
NEOFECT creates hope for a better world and a better life. We provide product and services to recover health and happiness in life for those who have lost hope. The Smart Rehabilitation Solution is designed to create a fun environment for rehabilitation training through interactive games content combined with smart IT technology. The smart device provides objective data to assist care-givers in providing the best possible methods for patient recovery. NEOFECT is leading the world’s rehabilitation market into the future.