Ai-BrainScience Inc. (Office: Osaka, Japan, CEO; Kentaro Takamura, Ph.D.) announces that the company is certified with ISO 13485:2016 on 23 December 2022, the international standard for quality management system for medical devices.

We obtained the certification from BSI Group Japan K.K.* (Office: Ocean Gate Minato-Mirai 3F, 3-7-1 Minato-Mirai, Nishi-ku, Yokohama-city, Kanagawa-Prefecture, Japan).

The ISO 13485 certificate can demonstrate the company’s competency to meet customer and regulatory requirements applicable to the quality management system for the medical devices.

* BSI Group Japan K.K. is the Japanese subsidiary of BSI group (British Standards Institution), the world-class standard body providing standards development, assessment and certification.