Tata Elxsi Limited launched AnaTel, an AI-native software development platform for healthcare and medical technology companies, co-developed with OpenAna. The platform debuted at DeviceTalks Boston 2026, where Tata Elxsi presented its AI-powered MedTech engineering and compliance capabilities.
AnaTel helps medical device and software-as-a-medical-device companies accelerate software development and generate regulatory-grade documentation. Tata Elxsi said the platform can reduce development cycle times by up to 60% and shorten SaMD development and change assessment timelines from eight weeks to 72 hours.
The platform embeds autonomous AI agents into the engineering workflow, operating across the full software delivery lifecycle from requirements through deployment, verification, validation, and continuous optimisation. It generates code, documentation, test cases, and regulatory artefacts, drawing on a Healthcare and Life Sciences expert agent fine-tuned for medtech regulatory contexts. Human engineers and regulatory experts remain in control at critical review and decision points. The platform supports eSTAR-aligned submission preparation, requirements traceability matrices, and audit-trail documentation as part of day-to-day engineering.
The launch comes as regulatory expectations rise, including the FDA's 2025 draft guidance on AI-Enabled Device Software Functions and Europe's MDCG 2025-26, which require lifecycle documentation, traceability, and validation evidence as part of engineering workflows. Tata Elxsi said requirements and regulatory artifacts have typically been assembled manually across disconnected tools, with every software change becoming a documentation exercise.
Sreevatsa Sahasranaman, Senior Vice President and Head of Healthcare and Life Sciences at Tata Elxsi, said AnaTel accelerates regulatory-ready software engineering by bringing autonomous AI agents into development workflows that shape compliance and submission readiness. Rajiv Sondhi, Chief Executive Officer of OpenAna, said the partnership brings autonomous AI agents into regulated healthcare and medtech, where lifecycle traceability, safety, and compliance are as important as speed. AnaTel was co-developed through STEP.UP, Tata Elxsi's co-innovation programme for high-potential deep-tech companies.
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