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.
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
​
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.
​​
Early Risk Visibility Across Your Workflow
Spot clinical and compliance risks early by linking potential hazards to development milestones.
​
Gap Analysis Dashboard
See your compliance readiness in real time. Spot gaps in evidence, traceability, and testing.
​
​
Adversarial Testing Toolkit
Stress test your AI models for robustness and bias—automatically generate risk evidence.
​
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.
Get Started
Build. Ship. Stay Compliant—No Guesswork Required
Connect your tools
Plug LensAI into Jira, GitHub and host of other connectors to quickly start your compliance journey.
Auto-map your regulations
Your tasks are instantly mapped to relevant compliance frameworks.
Run Gap & Risk Analysis
Identify what’s missing across traceability, risk, and documentation.
​
Who It's for
Built for AI Builders, Trusted by Hospitals
AI Developers, Engineers
Embed compliance directly in your workflow.
​​
​
Founders, Product Leaders
De-risk your pilot and GTM with built-in governance.
​
Quality, Regulatory Teams
Replace manual spreadsheets with real-time traceability.
​
Clinical Innovation Teams
Pilot faster, document better, scale confidently
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
