Fujitsu has announced a collaboration with DT-Axis to advance digital health innovation by supporting the development and commercialisation of Software as Medical Devices (SaMD). The two companies have signed a Memorandum of Understanding (MoU) to provide comprehensive assistance to research institutions, medical device manufacturers and pharmaceutical companies involved in SaMD development.

The collaboration aims to support the entire SaMD development lifecycle, including system design, regulatory approval processes, sales preparation and post-market operations. By combining their expertise, the companies intend to help organisations overcome existing challenges in Japan related to regulatory compliance and cross-functional system development required for bringing digital medical solutions to market.

Software as Medical Devices—such as therapeutic mobile applications and AI-powered medical imaging diagnostics—are increasingly being recognised globally for their potential to support disease prevention, health promotion and clinical treatment. However, despite promising research outcomes in Japan, many institutions face difficulties in building development frameworks that meet strict regulatory standards and support smooth commercialisation.

Through this partnership, Fujitsu will leverage its healthcare system development expertise and operational experience to develop programmable medical devices and related digital platforms. The company will also support post-sales system operation and maintenance while offering its Healthcare Personal Service Platform, which enables secure and reliable management of health and medical data.

Meanwhile, DT-Axis brings experience in obtaining manufacturing and marketing approvals for programmable medical devices, including those developed through outsourced manufacturing with Fujitsu. DT-Axis will focus on regulatory strategy, approval applications and sales readiness, ensuring smoother product development and market entry.

Looking ahead, the companies also plan to explore the creation of a dedicated SaMD distribution platform. This initiative aims to establish a broader ecosystem that provides integrated support—from development and regulatory approval to distribution—helping accelerate the adoption of digital healthcare technologies and improving patient outcomes.

Through the collaboration, both organisations aim to strengthen the digital health ecosystem and contribute to improved healthcare services and well-being by enabling faster and more reliable development of innovative medical software solutions.