塔塔电子推出AnaTel™，一个由OpenAna驱动的医疗保健和医疗技术领域的AI原生软件开发平台

AnaTel™ helps medical device and SaMD companies accelerate software development, generate regulatory-grade documentation, and reduce development cycle times by up to 60%

AnaTel™ 帮助医疗器械和独立软件作为医疗设备（SaMD）公司加速软件开发、生成符合监管要求的文档，并将开发周期时间缩短多达 60%。

BENGALURU, India

印度班加罗尔

,

，

May 27, 2026

2026年5月27日

/PRNewswire/ -- 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 .

/PRNewswire/ -- 全球设计和技术服务领域的领导者塔塔埃尔克斯公司（Tata Elxsi）今天宣布推出AnaTel™，这是一个专为医疗和医疗技术公司打造的原生人工智能软件开发平台，由塔塔埃尔克斯与自主AI工程平台提供商OpenAna共同开发。AnaTel™将在DeviceTalks Boston 2026首次亮相，届时塔塔埃尔克斯将展示其最新进展。

AI-powered MedTech

人工智能驱动的医疗科技

engineering and compliance.

工程与合规。

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 Regulatory expectations for AI-enabled device software are rising, with the FDA's 2025 draft guidance on AI-Enabled Device Software Functions and Europe's MDCG 2025-26 both requiring rigorous lifecycle documentation, traceability, and validation evidence as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.

医疗保健和医疗技术软件团队面临着日益严峻的运营挑战。对于人工智能驱动的设备软件，监管要求正在不断提高。美国食品药品监督管理局（FDA）2025年关于人工智能驱动设备软件功能的草案指南以及欧洲MDCG 2025-26文件均要求在核心工程工作流程中提供严格的产品生命周期文档、可追溯性及验证证据，而非作为事后提交的补充材料。

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..

结果是一个熟悉的瓶颈：需求、测试用例、可追溯性矩阵和监管文档在互不连接的工具中手动组装。每次软件变更都变成了一项文档工作。每个提交周期都从头开始。

AnaTel™ addresses this by embedding autonomous

AnaTel™ 通过嵌入自主功能来解决这个问题

AI agents

人工智能代理

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.

直接融入工程工作流程。与仅专注于代码生成的开发者生产力工具不同，AnaTel™ 贯穿整个 AI 驱动的软件交付生命周期，从需求和架构到部署、验证和确认，再到持续优化，使其成为适用于受监管环境的真正端到端工程执行平台。

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 .

作为可配置的AI软件团队，AnaTel™生成代码、文档、测试用例和监管文件，依托专门针对医疗保健和生命科学领域优化的专家代理。

medtech regulatory and engineering

医疗技术法规与工程

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.

在每个关键的审查和决策点上，人类工程师和监管专家仍然掌控着控制权。该平台支持与eSTAR一致的提交准备、需求可追溯性矩阵、验证和确认证据以及审计跟踪文档，作为日常工程的一部分。

It is expected to reduce SaMD development and change assessment timelines from eight weeks to 72 hours, with productivity improvements of up to 60%..

预计可将SaMD的开发和变更评估时间从八周缩短至72小时，生产力提升幅度高达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.

AnaTel™ 借助了 Tata Elxsi 在高度监管的医疗设备环境中构建软件的丰富经验，其工程深度不仅影响了平台的部署方式，还塑造了平台在可追溯性、验证和合规性方面的推理方式。

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.

塔塔埃尔克西带来以设计为主导、以人工智能为先的工程、深厚的领域专业知识，以及接触全球医疗保健和医疗技术企业的机会；OpenAna则带来平台和技术革新。

Sreevatsa Sahasranaman, Senior Vice President and Head, Healthcare and Life Sciences, Tata Elxsi:

Sreevatsa Sahasranaman，塔塔埃尔克斯公司高级副总裁兼医疗保健和生命科学部门负责人：

'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™ 通过将自主人工智能代理直接引入塑造合规性和提交准备情况的开发工作流程，加速了符合监管要求的软件工程，同时确保我们的客户工程和监管专家始终保持掌控。'

Rajiv Sondhi, Chief Executive Officer, OpenAna:

拉吉夫·索尼，首席执行官，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.

“我们在OpenAna的使命是提供作为可靠合作工程师与人类团队并肩工作的自主AI代理。与Tata Elxsi在AnaTel™上的合作将这一能力引入到最具挑战性的领域之一——受监管的医疗保健和医疗技术领域，在这里生命周期可追溯性、安全性和合规性与速度同样重要。”

Tata Elxsi's domain expertise and AI-first engineering ensure the platform is genuinely contextualized for the regulatory realities medtech teams face every day.'.

塔塔电子的领域专业知识和以人工智能为先的工程确保该平台真正适应医疗技术团队每天面临的监管现实。

Muthusamy Selvaraj, VP, Innovation and Partnerships, Healthcare and Life Sciences, Tata Elxsi:

穆图萨米·塞尔瓦拉吉，塔塔埃尔克斯医疗与生命科学创新与合作副总裁：

'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.'.

“导致AnaTel™的问题很简单：如果世界上最好的自主工程能力真正理解了医疗保健，它会变成什么？这个问题促成了与OpenAna的这种合作关系，也是STEP.UP在实践中如何运作的方式。我们对结果负责。这就是这个模型的不同之处。”

AnaTel™ is co-developed through STEP.UP, Tata Elxsi's co-innovation program for high-potential deep-tech companies.

AnaTel™ 是通过 Tata Elxsi 的高潜力深科技公司共同创新计划 STEP.UP 联合开发的。

About Tata Elxsi

关于塔塔埃尔克斯

Tata Elxsi is a global design and technology services company supporting customers across industries including healthcare and life sciences. In Med-Tech, Tata Elxsi works with medical device companies across product engineering, digital health, regulatory support, connected devices, and lifecycle transformation.

塔塔埃尔克西是一家全球设计和技术服务公司，为包括医疗保健和生命科学在内的各行业客户提供支持。在医疗技术领域，塔塔埃尔克西与医疗器械公司合作，涉及产品工程、数字健康、法规支持、互联设备和生命周期转型等方面。

The Healthcare and Life Sciences practice is ISO 13485 certified..

医疗保健和生命科学实践已通过ISO 13485认证。

For more information, please visit:

更多信息，请访问：

www.tataelxsi.com

www.tataelxsi.com

About OpenAna

关于OpenAna

OpenAna is the creator of Ana, a Platform of Autonomous Engineers spanning software engineering, security, DevOps/SRE, and AI/ML, designed to transform how software is built and delivered at enterprise scale. Ana operates autonomously across the full engineering lifecycle, from design and coding to testing, deployment, and documentation, enabling enterprises to ship faster, reduce manual effort, and maintain quality and governance at scale..

OpenAna 是 Ana 的创建者，Ana 是一个涵盖软件工程、安全、DevOps/SRE 以及 AI/ML 的自主工程师平台，旨在变革企业级规模下软件的构建与交付方式。Ana 能够在整个工程生命周期中自主运行，从设计、编码到测试、部署和文档编写，帮助企业更快发布产品、减少人工投入，并在大规模情况下保持质量和治理。

Learn more at

了解更多信息，请访问

www.openana.ai

www.openana.ai

Logo:

标志：

https://mma.prnewswire.com/media/742257/Tata_Elxsi_Logo.jpg

https://mma.prnewswire.com/media/742257/Tata_Elxsi_Logo.jpg

SOURCE Tata Elxsi

来源：塔塔埃尔克斯

21

21

%

%

more press release views with

更多新闻发布视图与

Request a Demo

请求演示