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Japan-based Fujitsu and DT-Axis have announced the commencement of a collaboration aimed at advancing digital health. The two companies have signed a Memorandum of Understanding to provide comprehensive support for the development of Software as Medical Device (SaMD), including regulatory approval and sales, for research and development institutions, as well as medical device and pharmaceutical companies.
SaMD, such as therapeutic applications and AI-powered image diagnostics, are expected to contribute significantly to health promotion, preventive medicine, and treatment, with their development and medical device approval progressing globally.
However, in Japan, even with promising research results and technologies applicable to SaMD, challenges remain in establishing a system design and development framework capable of ensuring compliance with regulatory requirements and enabling cross-functional implementation all the way to commercialisation.
Leveraging their respective business expertise and achievements, both companies will address these challenges by supporting the relevant companies and organisations in establishing system development frameworks from the initial development stages through post-market operation and maintenance. This collaboration will contribute to improving the quality and speed of SaMD development.
Going forward, both companies will continue to explore the establishment of a SaMD distribution platform for the relevant organisations and companies, alongside their SaMD development support. Through this, they aim to build an ecosystem that provides one-stop support from SaMD development to distribution, thereby contributing to the improvement of people's well-being.
