Tata Elxsi, a global provider of design and technology services, has announced the launch of AnaTel™, an AI-native software development platform designed specifically for healthcare and medical technology companies. Co-developed with OpenAna, a specialist in autonomous AI engineering platforms, AnaTel™ aims to help medical device and Software as a Medical Device (SaMD) companies accelerate development timelines, strengthen regulatory readiness, and improve engineering productivity.
The platform is being introduced at DeviceTalks Boston 2026, where Tata Elxsi is showcasing its latest innovations in AI-powered engineering and compliance solutions for the medtech sector. As healthcare software systems become more advanced, regulatory requirements surrounding AI-enabled medical devices are also increasing. Recent regulatory frameworks, including the FDA’s 2025 draft guidance on AI-enabled device software and Europe’s MDCG 2025-26 guidelines, have intensified the need for lifecycle traceability, validation evidence, and comprehensive documentation throughout the engineering process. For many organizations, these demands continue to create delays due to fragmented workflows and extensive manual documentation requirements.
AnaTel™ has been developed to address these challenges by integrating autonomous AI agents directly into the software engineering lifecycle. Unlike conventional coding assistants focused primarily on code generation, AnaTel™ supports the entire AI-driven software delivery process, including requirements engineering, architecture design, verification and validation, deployment, optimization, and regulatory documentation.
The platform functions as a configurable AI-powered engineering environment capable of generating code, test cases, traceability matrices, validation evidence, and regulatory artifacts. It incorporates a specialized Healthcare and Life Sciences expert agent trained specifically for medtech engineering and compliance requirements. Human engineers and regulatory specialists continue to oversee all critical reviews and approvals, ensuring operational control and governance remain intact.
According to Tata Elxsi, AnaTel™ supports eSTAR-aligned submission preparation, audit-trail management, and end-to-end traceability as part of everyday engineering operations. The company expects the platform to reduce software development and change assessment timelines from several weeks to as little as 72 hours, while delivering productivity gains of up to 60 percent.
Sreevatsa Sahasranaman, Senior Vice President and Head of Healthcare and Life Sciences at Tata Elxsi, said the platform has been designed to simplify the path toward regulatory-ready software development while maintaining strong human oversight. Rajiv Sondhi, Chief Executive Officer of OpenAna, noted that the partnership combines autonomous AI engineering capabilities with deep healthcare domain expertise to address the unique operational and compliance demands faced by medtech organizations.
AnaTel™ has been developed under STEP.UP, Tata Elxsi’s co-innovation initiative focused on supporting high-potential deep-tech collaborations and accelerating next-generation enterprise technologies. Tata Elxsi is a global provider of design and engineering services, working with customers across automotive, broadcast, communications, healthcare, and transportation industries. The company helps organizations develop products, platforms, and services by combining engineering expertise with design, digital technologies, and deep industry knowledge.
