News

B dot Medical Inc. (Headquarters: Edogawa, Tokyo; President & CEO: Takuji Furukawa) is pleased to announce that it has officially obtained ISO 13485:2016 certification, the international standard for medical device quality management systems (QMS).

B dot Medical has previously demonstrated the safety and efficacy of its products by obtaining manufacturing and marketing approval under Japan’s PMD Act (Pharmaceuticals and Medical Devices Act) for its ultra-compact proton therapy system, Phemto®, and its shuttle treatment table, Throup®. Achieving ISO 13485 certification serves as public validation that the company’s quality management system meets rigorous global standards. This represents a critical milestone in strengthening the company’s business foundation for both domestic and international expansion.

Significance of the Certification
・A “License of Trust” as an Organization
ISO 13485 requires strict quality control throughout the entire lifecycle of a medical device. By obtaining this certification for the Throup® shuttle treatment table, B dot Medical has proven that its integrated operations—from development and manufacturing to quality control—reach an advanced level of global excellence.

・A Solid Foundation as a Medical Device Manufacturer
The combination of public approvals for products and organizational QMS certification completes the company’s platform for sustainable growth. Phemto®, which has already received regulatory approval in Japan, will be managed under the same robust quality framework. Establishing organizational quality assurance that is independent of specific products strengthens B dot Medical’s governance and business continuity.

・Accelerating Global Expansion
ISO 13485 is a de facto requirement for entering global markets. This certification will enable B dot Medical to facilitate faster business development and build high-level trust when engaging with major medical institutions worldwide.
　
Message from Takuji Furukawa, President & CEO
“B dot Medical has steadily built a track record by obtaining regulatory approvals for our products. This ISO 13485 certification demonstrates that the ‘organizational quality’ supporting our products has reached a global standard. With our quality foundation firmly in place, we are committed to rapidly delivering Phemto® and Throup® to medical institutions worldwide and advancing the widespread adoption of next-generation cancer treatment.”
　
ISO 13485 Certification Details
Standard: EN ISO 13485:2016 + AC:2018 + A11:2021; ISO 13485:2016
Registration No.: SX 2697823-1
Scope: Design and Development and Manufacture of Treatment Couches for Radiation Therapy
Issue Date: March 9, 2026
Certification Body: TÜV Rheinland Japan Ltd.
　
　
　
Product Name: Proton Therapy System Phemto®, Medical Device Approval Number: 30500BZX00274000
Product Name: Shuttle Treatment Table Throup, Medical Device Filing Number: 13B1X10334000001
*Approval from regulatory authorities in each country is required for clinical use outside of Japan.