Your Gateway for StreamlinedRegulatory Excellence

Explore our powerful features crafted to simplify your regulatory process and speed up your product launch.

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Faster Processing

Secure & Compliant

Advanced Predicate Search

Search the FDA’s 510(k) database using intuitive, natural language prompts no complex filters or keyword guesswork.

Find the most relevant predicates in seconds, not hours.

Detailed Regulatory Reporting

Generate expert level reports that compile and contextualise FDA data to support your substantial equivalence narrative.

Strengthen your submission with clear documentation.

Secure and Compliant

All user activity and file transfers are protected with industry-standard encryption. It is engineered with FDA guidelines and meets HIPAA and GDPR requirements.

Enterprise protection for your sensitive information.

Device Comparison

Easily compare device specs, testing protocols, and regulatory pathways side by side, in one view.

Spot differences, justify similarities, and make faster decisions.

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A lot of medical device companies already using our platform to accelerate their regulatory submissions.