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.