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Make Your Healthcare AI Real-World Ready

LensAI brings FDA compliance into your AI development process automatically. We help you generate 510(k)-ready documentation, trace features to requirements, and stay aligned with FDA and ISO standards all from your existing tools.
 

Stay audit-ready and accountable, even if you're not going through FDA or regulatory review.

Overview LensAI

Medical AI Failures Aren’t Just Bugs. They’re Clinical Risks.
What feels like a model oversight in development can turn into regulatory violations or worse, patient harm in production. 

Silent Model Drift → Clinical Misdiagnosis

44%

AI-enabled medical devices recalled by the FDA in the last 2 years were flagged for undocumented model behavior and lack of traceability.

60%

Hospital Pilots Fail Due to Compliance Gaps

Hospitals now demand audit-ready documentation before green-lighting pilots. Without evidence aligned to FDA, EU AI Act, and ISO 42001, even high-performing models don’t get deployed.

 Healthcare AI Products Struggle With Regulatory Readiness

72%

Investors and enterprise buyers increasingly require a traceability matrix, risk register, and proof of ongoing monitoring.

Requirements Across Global AI Regulations

200

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It is hard to map your development  work to these frameworks in real time—so you stay compliant without slowing down.

The GRC Platform for
Healthcare AI Teams

LensAI transforms your AI development process into a compliant, audit-ready pipeline.

Compliance Tracker

Map your project workflows with tasks directly to frameworks like FDA SaMD, EU AI Act, ISO 42001, and GMLP.

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Early Risk Visibility Across Your Workflow

Spot clinical and compliance risks early by linking potential hazards to development milestones.

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Gap Analysis Dashboard

See your compliance readiness in real time. Spot gaps in evidence, traceability, and testing.

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Adversarial Testing Toolkit

Stress test your AI models for robustness and bias—automatically generate risk evidence.

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Submission-Ready Reports

Export traceability matrices, risk logs, and documentation for pre-submissions and audits.

Coming soon...
Built-in Risk Register with ISO 14971 and CVSS-aligned scoring, so you can manage, score, and resolve risks from one place.

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Product Demo

Get Started

Build. Ship. Stay Compliant—No Guesswork Required

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Connect your tools

Plug LensAI into Jira, GitHub and host of other connectors to quickly start your compliance journey. 

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Auto-map your regulations

Your tasks  are instantly mapped to relevant compliance frameworks.

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Run Gap & Risk Analysis

Identify what’s missing across traceability, risk, and documentation.

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Who It's for

Built for AI Builders, Trusted by Hospitals

AI Developers,  Engineers

Embed compliance directly in your workflow.

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Founders, Product Leaders

De-risk your pilot and GTM with built-in governance.

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Quality, Regulatory Teams

Replace manual spreadsheets with real-time traceability.

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Clinical Innovation Teams

Pilot faster, document better, scale confidently

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Trusted by AI Builders. Guided by Global Standards.

In the journey of partnering with the Coalition for Health AI (CHAI) to advance AI assurance, safety, and transparency in clinical settings.

Supported by top experts in AI , Compliance , Regulatory Affairs, Security and Healthcare 

Mapped against 700+ FDA-cleared SaMD

CMU Cylab
Nvidia Inception Program
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AI Compliance Built for Healthcare.

 

LensAI helps you build hospital-ready AI systems by integrating regulatory alignment, traceability, and evidence management—mapped to FDA, EU AI Act, ISO 42001, and GMLP.

Made with Global Spirit 

 ðŸ‡ºðŸ‡¸ Pittsburgh +  🇩🇪 Berlin 

Your AI is powerful. Let’s make it compliant—without slowing you down.

© 2025 by lensai.

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