TÜV Rheinland Issues EC certificate for Cyberdyne’s Medical Robot Suit HAL®
Global testing, inspection and certification body, TÜV Rheinland has issued an EC certificate for Cyberdyne’s Robot Suit HAL®. The product was evaluated under the Medical Device Directive (MDD) and was certified compliant with all harmonized standards that are applicable. This is the first robot for medical treatment purpose developed using Japan’s innovative technology. With CE marking, HAL® will be offered as a medical device for the European market, which accounts for about 34% of the global medical device market.
Cyberdyne was formed as part of a project at the University of Tsukuba and established as a venture company in 2004. It has been engaged in the research , development and implementation of HAL®, a robot suit created by applying leading-edge cybernics* technology. Cyberdine has focused on research and development of both basic and advanced technology to introduce HAL® as a medical device, while focusing on the business aspects of offering HAL® domestically and globally. Its efforts have included establishing and obtaining certification as a medical device. To produce an innovative robot for medical treatment like HAL®, Cyberdyne obtained certification of quality management according to ISO 13485 - quality management systems for medical devices in December 2012. And now HAL® is certified as a medical device by TÜV Rheinland to be marketed in Europe. To comply with the requirements, safety technology developed by the NEDO Life Support Robot Project was applied together with a clinical study by the FIRST Project of the University of Tsukuba and Cabinet Office.
Cyberdyne applied to TÜV Rheinland, a notified body for MDD, for evaluation and certification. TÜV Rheinland performed conformity assessment according to 93/42/EEC and certified that HAL® complies with all applicable harmonized European standards. To evaluate safety, “Functional Safety” evaluation was also conducted to ensure strict risk management. Cyberdyne will also take the necessary steps to market HAL® as a medical device in other global markets.
*Cybernics – Integration of human, machine and information : New research domain, based on cybernetics, mechatronics and information technology and integrating neuroscience , robot engineering, IT technology, physiology, behavioral science, psychology, law, ethics and aesthetic study.