Obtained ISO 13485:2016 certification for quality management system for medical devices.
2021.02.12 Products
(Headquarters: Kobe City, Hyogo Prefecture) acquired ISO13485:2016 certification, an international standard for quality management systems in medical devices, in February 2021 for the manufacture of medical measuring instruments, with the aim of maintaining the safety and quality of medical devices, We are pleased to announce that we have obtained ISO13485:2016 certification, the international standard for quality management systems for medical devices, for the "manufacture of medical measuring instruments.
In October 2020, the Group launched sales of its first medical device, the AT Measure (joint motion tester), which utilizes the proprietary C-STRETCH® elastic strain sensor (manufactured by the Company (registered as a medical device manufacturer in July 2020) and sold by consolidated subsidiary Aimedic Inc. (manufactured by the Company (registered as a medical device manufacturer in July 2020) and sold by MMT, a consolidated subsidiary of the Company). With the acquisition of ISO13485:2016 certification, we will ensure the safety, effectiveness, and quality of medical devices, and will continue to improve the reliability of medical devices manufactured by our company and further contribute to society.
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