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.
Make Your AI Models Safer, Smarter, and Compliant
LensAI transforms your AI development process into a compliant, audit-ready pipeline.
Compliance Dashboard
Track your progress across global frameworks like FDA SaMD, EU AI Act, ISO 42001, and GMLP — all mapped directly to your project tasks.
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Model Security and Observability
Built to Detect, Monitor, and Comply Across the AI Lifecycle
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Real-time GAP Analysis
Quickly see what’s missing — whether it’s documentation, test coverage, or traceability — so you’re always audit-ready.
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Built-In Risk Intelligence
Track and manage risks across the AI lifecycle. Our scoring model incorporates ISO 42001 and NIST AI RMF.
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Robustness & Bias Testing
Automatically stress test your AI models against adversarial scenarios.
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Submission Ready Reports
Export traceability matrices, risk logs, and validation summaries in just a few clicks — formatted for pre-submissions, audits, and design reviews.
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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.
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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
Trusted by AI Builders. Guided by Global Standards.
Assurance Provider 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
