AnaTel™ helps medical device and SaMD companies accelerate software development, generate regulatory-grade documentation, and reduce development cycle times by up to 60%
Bengaluru, India, May 27, 2026: Tata Elxsi, a global leader in design and technology services, today announced the launch of AnaTel™, an AI-native software development platform for healthcare and medical technology companies, co-developed with OpenAna, a provider of autonomous AI engineering platforms. AnaTel™ makes its debut at DeviceTalks Boston 2026, where Tata Elxsi is presenting its latest advances in AI-powered MedTech engineering and compliance.
Healthcare and medtech software teams face a growing operational challenge. Regulatory expectations for AI-enabled device software are rising, with the FDA's 2025 draft guidance on AI-Enabled Device Software Functions and Europe's MDCG 2025-26 both requiring rigorous lifecycle documentation, traceability, and validation evidence as part of core engineering workflows, not submission afterthoughts. The result is a familiar bottleneck: requirements, test cases, traceability matrices, and regulatory artifacts are assembled manually across disconnected tools. Every software change becomes a documentation exercise. Every submission cycle starts from scratch.
AnaTel™ addresses this by embedding autonomous AI agents directly into the engineering workflow. Unlike developer productivity tools that focus on code generation alone, AnaTel™ operates across the full AI-Driven Software Delivery Lifecycle, from requirements and architecture through deployment, verification and validation, and continuous optimization, making it a true end-to-end engineering execution platform for regulated environments. Operating as a configurable AI software team, AnaTel™ generates code, documentation, test cases, and regulatory artifacts, drawing on a dedicated Healthcare and Life Sciences expert agent fine-tuned for medtech regulatory and engineering contexts. Human engineers and regulatory experts remain in control at every critical review and decision point. The platform supports eSTAR-aligned submission preparation, requirements traceability matrices, verification and validation evidence, and audit-trail documentation as part of day-to-day engineering. It is expected to reduce SaMD development and change assessment timelines from eight weeks to 72 hours, with productivity improvements of up to 60%.
AnaTel™ draws on Tata Elxsi's extensive experience building software in highly regulated medical device environments, engineering depth that has shaped how the platform reasons about traceability, validation, and compliance, not just how it is deployed.
Tata Elxsi brings design-led and AI-first engineering, deep domain expertise, and access to global healthcare and medtech enterprises; OpenAna brings platform and technology innovation.
Sreevatsa Sahasranaman, Senior Vice President and Head, Healthcare and Life Sciences, Tata Elxsi: “AnaTel™ accelerates regulatory-ready software engineering by bringing autonomous AI agents directly into the development workflows that shape compliance and submission readiness, while keeping our customers' engineering and regulatory experts firmly in control."
Rajiv Sondhi, Chief Executive Officer, OpenAna: “Our mission at OpenAna is to provide autonomous AI agents that work as reliable co-engineers alongside human teams. Partnering with Tata Elxsi on AnaTel™ brings this capability into one of the most demanding domains, regulated healthcare and medtech, where lifecycle traceability, safety, and compliance are as important as speed. Tata Elxsi's domain expertise and AI-first engineering ensure the platform is genuinely contextualized for the regulatory realities medtech teams face every day.”
Muthusamy Selvaraj, VP, Innovation and Partnerships, Healthcare and Life Sciences, Tata Elxsi: “The question that led to AnaTel™ was a simple one: what could the world's best autonomous engineering capability become if it truly understood healthcare? That question is how this partnership with OpenAna was born, and it is how STEP.UP works in practice. We are accountable for the outcome. That is what makes this model different.”
AnaTel™ is co-developed through STEP.UP, Tata Elxsi's co-innovation program for high-potential deep-tech companies.
