Tata Elxsi has introduced the launch of AnaTel™, an AI-native software program improvement platform for healthcare and medical expertise firms, co-developed with OpenAna, a supplier of autonomous AI engineering platforms.
AnaTel™ makes its debut at DeviceTalks Boston 2026, the place Tata Elxsi is presenting its newest advances in AI-powered MedTech engineering and compliance.
Healthcare and medtech software program groups face a rising operational problem. Regulatory expectations for AI-enabled system software program are rising, with the FDA’s 2025 draft steerage on AI-Enabled System Software program Capabilities and Europe’s MDCG 2025-26 each requiring rigorous lifecycle documentation, traceability, and validation proof as a part of core engineering workflows, not submission afterthoughts.
AnaTel™ addresses this by embedding autonomous AI brokers straight into the engineering workflow. AnaTel™ operates throughout the complete AI-Pushed Software program Supply Lifecycle, from necessities and structure via deployment, verification and validation and steady optimization, making it a real end-to-end engineering execution platform for regulated environments. Working as a configurable AI software program group, AnaTel™ generates code, documentation, take a look at circumstances and regulatory artifacts, drawing on a devoted Healthcare and Life Sciences professional agent fine-tuned for medtech regulatory and engineering contexts.
Human engineers and regulatory consultants stay in management at each crucial overview and choice level. The platform helps eSTAR-aligned submission preparation, necessities traceability matrices, verification and validation proof, and audit-trail documentation as a part of day-to-day engineering. It’s anticipated to cut back SaMD improvement and alter evaluation timelines from eight weeks to 72 hours, with productiveness enhancements of as much as 60%.
AnaTel™ attracts on Tata Elxsi’s intensive expertise constructing software program in extremely regulated medical system environments, engineering depth that has formed how the platform causes about traceability, validation, and compliance, not simply how it’s deployed.
Sreevatsa Sahasranaman, Senior Vice President and Head, Healthcare and Life Sciences, Tata Elxsi: “AnaTel™ accelerates regulatory-ready software program engineering by bringing autonomous AI brokers straight into the event workflows that form compliance and submission readiness, whereas holding our clients’ engineering and regulatory consultants firmly in management.”
Rajiv Sondhi, Chief Government Officer, OpenAna: “Our mission at OpenAna is to supply autonomous AI brokers that work as dependable co-engineers alongside human groups. Partnering with Tata Elxsi on AnaTel™ brings this functionality into probably the most demanding domains, regulated healthcare and medtech, the place lifecycle traceability, security, and compliance are as essential as velocity. Tata Elxsi’s area experience and AI-first engineering make sure the platform is genuinely contextualized for the regulatory realities medtech groups face day by day.”
Muthusamy Selvaraj, VP, Innovation and Partnerships, Healthcare and Life Sciences, Tata Elxsi: “The query that led to AnaTel™ was a easy one: what might the world’s finest autonomous engineering functionality change into if it actually understood healthcare? That query is how this partnership with OpenAna was born, and it’s how STEP.UP works in observe. We’re accountable for the end result. That’s what makes this mannequin completely different.”
AnaTel™ is co-developed via STEP.UP, Tata Elxsi’s co-innovation program for high-potential deep-tech firms.