Fujitsu & DT-Axis Collaborate to Advance SaMD Development & Digital Health

Both have also indicated plans to explore the creation of a SaMD distribution platform, providing companies with end-to-end support, from product design and regulatory approval to distribution and deployment in healthcare settings.

Japan-based technology company Fujitsu and healthcare regulatory specialist DT-Axis have joined forces to strengthen digital health innovation by supporting the development and commercialization of Software as a Medical Device (SaMD).

The collaboration is designed to assist research institutions, medical device manufacturers, and pharmaceutical companies in navigating complex regulatory processes while accelerating the creation of clinically validated digital health solutions.

The two organizations have signed a memorandum of understanding to provide comprehensive support across the SaMD development lifecycle, from early-stage system design to regulatory approval, deployment, and post-market operations.

By combining their expertise, Fujitsu and DT-Axis aim to improve both the efficiency and reliability of SaMD development in Japan’s rapidly evolving healthcare technology landscape.

The collaboration between Fujitsu and DT-Axis seeks to help companies design compliant development environments and operational workflows from the earliest stages of product creation, including guidance on regulatory submissions, product design validation, system implementation, and post-market monitoring once a device has been approved.

Fujitsu brings extensive experience in healthcare technology infrastructure and system development to the partnership. The company has long been involved in building programmable medical device systems as well as supporting healthcare institutions with digital platforms that manage clinical and operational data.

Its Healthcare Personal Service Platform, for instance, provides a secure environment for storing and managing personal health information, enabling organizations to handle sensitive medical data while meeting strict privacy requirements.

DT-Axis complements this technical capability with regulatory expertise. The company has previously supported the approval process for programmable medical devices manufactured through Fujitsu’s systems.

Through this collaboration, DT-Axis will focus on guiding organizations through approval applications and ensuring that products are ready for commercialization once regulatory clearance is obtained.

Beyond development and approval support, the two companies have also indicated plans to explore the creation of a SaMD distribution platform. Such an ecosystem could provide companies with end-to-end support, from product design and regulatory approval to distribution and deployment in healthcare settings.

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