At last month’s DeviceTalks show in Boston, Massachusetts, Tata Elxsi announced AnaTel, an AI-native software development platform for healthcare and medical technology companies, co-developed with OpenAna, a provider of autonomous AI engineering platforms.

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 Regulatory expectations for AI-enabled device software are rising, with the FDA’s 2025 draft guidance on AI-enabled device software functions and Europe’s MDCG 2025-26, both requiring rigorous lifecycle documentation, traceability and validation evidence as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 artefacts 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 optimisation, making it an end-to-end engineering execution platform for regulated environments.

Operating as a configurable AI software team, AnaTel generates code, documentation, test cases and regulatory artefacts, 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 development and change assessment timelines and improve productivity.

“Our mission at OpenAna is to provide autonomous AI agents that work as reliable co-engineers alongside human teams,” said Rajiv Sondhi, CEO at OpenAna. “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 contextualised for the regulatory realities medtech teams face every day.”

Sreevatsa Sahasranaman, senior vice president at Tata Elxsi, added: “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.”

AnaTel was co-developed through Step.Up, Tata Elxsi’s co-innovation programme for high-potential deep-tech companies.

Part of the Indian Tata group, Elxsi (www.tataelxsi.com) is a design and technology services company supporting customers across industries including healthcare and life sciences.

Maryland-based OpenAna (www.openana.ai) is the creator of Ana, a platform for autonomous engineers spanning software engineering, security, devops, AI and machine learning, designed to transform how software is built and delivered at enterprise scale.