AI Medical Service Inc. Acquires ISO 13485 Certification, an international standard for quality management systems (QMS) specific to the medical device industry

AI MEDICAL SERVICE INC. (hereinafter AIM), a medical start-up specializing in the development of diagnostic endoscopic AI, announces the acquisition of ISO 13485 certification on December 6, 2022. The ISO certification is an international standard for quality management systems specific to the medical device industry.

■Background of Acquisition of ISO 13485 Certification

AIM is a medical AI startup company engaged in the research and development of AI to support the diagnosis of gastric cancer. AIM’s mission is to "Save Lives All Over the World” and achieve ‘zero missed cancer’ through endoscopic AI. From the start, AIM has advanced business activities with the intent to expand globally and take on the challenges of overlooked or misdiagnosed cancer.

AIM is preparing for overseas expansion by establishing local subsidiaries in Silicon Valley (opened in January 2022) and Singapore (opened in July 2022). To fully expand business activities into regions like Europe and the United States, it is mandatory to first obtain ISO 13485 certification.

As a company engaged in the business of medical devices, AIM places an utmost importance on ensuring safety and quality. Given the significant impact that medical devices can have on human lives, AIM has always managed its products in accordance with strict standards developed internally. Even after ISO certification, AIM will continue its efforts to establish a product development process that is compliant with the global standards ensuring safety and quality.

■About ISO 13485

ISO 13485 is an international standard that aims to standardize product development processes associated with safety, effectiveness, and quality. The standard is designed for adoption by organizations involved in the design, development, manufacture, and marketing of medical devices. ISO 13485 is designed to ensure that medical device manufacturers offer reliable medical devices and related services. As a result, acquiring ISO 13485 certification demonstrates that AIM has developed a product management system that complies with standards not only in Japan, but also overseas. 

 AIM has also recently received certification from TÜV SÜD, one of the world's leading third-party certification organizations.

■About AI Medical Service Inc.

AI Medical Service (AIM) is a Tokyo-based med-tech company established with the mission to “Save Lives All Over the World.” Japan leads the world in endoscopic diagnosis and treatment, providing firms and researchers with access to large amounts of high-quality data. AIM is the leading player in the field of endoscopic AI, engaging in joint research with more than 100 medical institutions. By bringing endoscopic AI to the real-world clinical setting as soon as possible, AIM aims to reduce the number of missed cancer diagnoses and save lives around the world.

■About CEO of AI Medical Service Inc., Dr. Tada

Tomohiro TADA, M.D., Ph.D.

Dr. Tomohiro TADA is the CEO of AI Medical Service Inc., the chairperson of Tada Tomohiro The Institute of Gastroenterology & Proctology, and Visiting Lecturer, Department of Surgical Oncology, Graduate School of Medicine, the University of Tokyo Hospital.

Dr. TADA received his M.D. of school of medicine in 1996 and Ph.D. of department of surgery in 2005 from the University of Tokyo. He trained in Colorectal Surgery at the University of Tokyo Hospital.

■Related Press Release

・Jan. 1 2023 “AI Medical Service Inc. Establishes US Second Base 〜Fortifying a framework for business expansion in the U.S.〜”

https://en.ai-ms.com/news/global/20230101

・Jul. 11, 2022 “AIM Establishes local subsidiary in Singapore 〜Accelerating the overseas expansion of “Endoscopic AI” by establishing a second overseas branch〜”

https://en.ai-ms.com/news/global/20220711

・Jan. 19, 2022 “AIM Establishes U.S. subsidiary in Silicon Valley as a first overseas branch”

https://en.ai-ms.com/news/global/20220129

・Apr. 27, 2021 “AIM and Singapore’s National University Hospital Sign Joint Research Agreement on Endoscopic AI 〜The research will be focused on testing the utility of Endoscopic AI in Singapore〜”

https://en.ai-ms.com/news/global/20210427

Company Profile　　――――――――――――――――――――――――――――――

Company： AI Medical Service Inc.
Address： Hareza Tower 11F, 1-18-1 Higashiikebukuro, Toshima-ku, Tokyo 170-0013, Japan
CEO： Tomohiro Tada
Founding： September 1, 2017
Business： Development of Endoscopic AI