AI Medical Service AI Medical Service acquired ISO13485, an international standard for quality management systems specialized in the medical device industry.

AI Medical Service
Acquired ISO13485, an international standard for quality management systems specialized in AI medical services and the medical device industry

AI Medical Service Co., Ltd. (Headquarters: Toshima-ku, Tokyo; CEO: Tomohiro Tada; hereinafter referred to as “AIM”), which develops AI (artificial intelligence) to support endoscopic image diagnosis, has announced that it will On December 6, 2022, we acquired ISO 13485, an international standard for standardized quality management systems. [Image 1

■ Background of acquisition of ISO13485
AIM is a medical AI start-up company engaged in the research and development of gastric cancer diagnosis support AI with the mission of “saving the world’s patients – endoscope AI to eliminate missed cancers -“. Cancer of the gastrointestinal tract, including stomach cancer, accounts for about 30% of all cancer deaths worldwide. Most of them are in a serious condition of advanced cancer. AIM is an endoscope AI developed by our company, and in order to solve these problems, we have been promoting our business with a view to global expansion from the beginning.
In addition, AIM will establish local subsidiaries in Silicon Valley in January 2022 and in Singapore in July 2022, and is preparing for overseas expansion. In order to develop business in certain countries and areas, especially in Europe and the United States, there are regions where it is essential to obtain this certification. I have been aiming for
As a company that develops medical equipment, a business that affects human life, we place the utmost importance on ensuring safety and quality above all else. It is recognized by a third-party organization that it conforms to international standards.
AIM will continue to work on building a medical device development system that conforms to global standards and ensuring safety and quality.
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■ About ISO 13485
ISO 13485 is an international standard aimed at maintaining the safety, efficacy and quality of medical devices, and is intended for organizations involved in the design, development, manufacture and sale of medical devices. It was created for the purpose of ensuring that medical device manufacturers provide stable medical devices and related services, and the acquisition of this certification means that AIM has complied with a global standard management system not only in Japan but also overseas. It’s proof that you’re working on it. AIM has recently obtained certification from TUV SUD, a world-class third-party certification body.
■ About AI Medical Service
AIM is a medical AI start-up company with the mission of “saving the world’s patients – Endoscope AI to zero missed cancers -“. Japan is at the forefront of endoscopic medicine, and we have accumulated the world’s highest level of data both in terms of quality and quantity. Among them, AIM is promoting joint research and product development with more than 100 medical facilities. By delivering endoscope AI to the medical field as soon as possible, we aim to reduce the number of cancers overlooked and save patients around the world.
■ About CEO Tomohiro Tada
Dr. Tomohiro Tada Doctor of Medicine
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CEO of AI Medical Service Co., Ltd.
Medical Corporation Tada Tomohiro Gastroenterology Proctology Director [Overview]
1996 Graduated from the University of Tokyo School of Medicine. Worked as a surgical intern at the University of Tokyo Hospital. In 2005, completed the doctoral course at the University of Tokyo Graduate School of Medicine. In 2006, he opened Tadahiro Gastroenterology and Proctology. Since 2012, he has been a visiting lecturer at the Department of Surgical Oncology, Faculty of Medicine, the University of Tokyo. Established AI Medical Service Co., Ltd. in 2017 and assumed the position of CEO.
■Press release related to overseas expansion of AIM
・April 27, 2021 “Concluded a joint research agreement with National University Hospital, Singapore”
・January 19, 2022 “Establishment of US corporation in Silicon Valley as the first overseas base”
・July 11, 2022 “AI Medical Service Establishes Local Subsidiary in Singapore – Accelerating Overseas Expansion of “Endoscope AI” by Establishing Second Overseas Base” (
・January 1, 2023 “AI Medical Services Opens Second U.S. Base in New York-Accelerating System Construction for Business Development in the U.S.-” ( /global/20230101)
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