Fujitsu and DT Axis have announced a strategic collaboration to accelerate the development, validation, and regulatory approval of Software as a Medical Device (SaMD) solutions in India and global markets. The partnership combines Fujitsu’s expertise in AI, cloud computing, and secure digital infrastructure with DT Axis’s deep domain knowledge in medical device regulations, quality systems, and clinical validation aiming to shorten time to market, reduce compliance risks, and bring clinically robust digital health products to patients faster.
Glimpse:
Under the agreement signed on January 28, 2026, Fujitsu will provide its advanced AI/ML platforms, secure cloud environments, and cybersecurity frameworks, while DT Axis contributes regulatory strategy, ISO 13485 & IEC 62304-compliant processes, clinical evaluation support, and risk management expertise. The collaboration targets SaMD applications in diagnostics, remote monitoring, predictive analytics, and chronic disease management. Initial joint projects are already underway, with first commercial SaMD solutions expected in 2026–2027.
Fujitsu Limited (Japan) and DT Axis Consulting (India) have formalised a strategic partnership to jointly advance the development and commercialisation of Software as a Medical Device (SaMD) products, with a strong focus on the Indian market and global scalability. The announcement, made on January 28, 2026, addresses a critical gap in India’s rapidly growing digital health ecosystem: the need for faster, more reliable pathways to regulatory clearance (CDSCO, US FDA, CE marking) while ensuring patient safety and data security.
Under the collaboration:
- Fujitsu will contribute its cutting-edge AI/ML capabilities, secure cloud infrastructure (Fujitsu Hybrid IT), cybersecurity solutions, and experience in large-scale digital health deployments
- DT Axis will provide end to end regulatory consulting, ISO 13485 & IEC 62304-compliant quality management systems, clinical evaluation planning, post-market surveillance strategies, and risk management expertise
The partnership targets SaMD categories with high clinical and commercial potential in India, including:
- AI-based diagnostic support tools (radiology, pathology, dermatology)
- Remote patient monitoring and chronic disease management platforms
- Predictive analytics for early warning of deterioration (sepsis, cardiac events)
- Digital therapeutics and personalised treatment planning engines
Both companies highlighted the urgency of robust SaMD development in India, where digital health adoption is accelerating under the Ayushman Bharat Digital Mission (ABDM), but regulatory and quality hurdles continue to slow innovation. The collaboration will also include joint training programmes for startups, shared regulatory intelligence, and co-creation of reference architectures for compliant, scalable SaMD.
Fujitsu India Executive stated: “India is one of the fastest-growing digital health markets globally. By partnering with DT Axis, we are combining world-class technology with local regulatory excellence to help innovators bring safe, effective SaMD solutions to market faster ultimately benefiting millions of patients.”
DT Axis leadership added: “Many promising SaMD products struggle to navigate the regulatory pathway. Our collaboration with Fujitsu provides a complete end to end solution from ideation and development to validation, submission, and post-market support making compliance a strength, not a barrier.”
The partnership is already supporting several joint projects, including AI tools for early TB detection, diabetic retinopathy screening, and remote cardiac monitoring. First commercially cleared SaMD products from the collaboration are targeted for launch in 2026–2027.
“SaMD is the future of healthcare delivery, but only if it is developed safely, ethically, and with regulatory confidence. This partnership gives innovators the best of both worlds cutting-edge AI from Fujitsu and regulatory mastery from DT Axis to bring life-changing digital health solutions to India and the world.”
By
HB Team
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