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Find the optimal path to approval with
AI-driven insights.
Detect gaps & minimize delays
Collaborate with experts and your team
to streamline workflows in-platform.
Instant audit-ready reports
Generate audit-ready reports
& submissions instantly.
Collaborate & streamline workflows
Stay ahead of regulations with
real-time tracking & alerts.
Real-time tracking & alerts
Detect compliance gaps before
submission & minimize delays.
Fast-track approvals with AI
This is a design mockup for illustrative purposes. The final interface may vary.
The average time it takes for a medical device company to reach the market.
The average cost of bringing a medical device to market.
The amount of US-specific guidance documents, standards, laws, and regulations.
The smartest regulatory search at your fingertips. Large Language Model search understands context and delivers precise regulatory insights in seconds.
Automatically create compliant, audit-ready documentation, including everything you need for setting up your company for regulatory success.
Sync your team, streamline approvals and workflows, and reduce compliance risk with real-time traceable infrastructure.
Reduce risk, eliminate bottlenecks, and fast-track approvals—all in one platform.
AI-powered insights help pinpoint the fastest regulatory pathway.
Spend less time messing with templates and instantly generate submission-ready documents.
Catch compliance gaps early to avoid costly delays and more work.
Create the required set of documents, and understand why.
Built for medical device companies—whether you're a startup or an enterprise—OneComplAI simplifies compliance at every stage.
Handle submissions and complex regulations with ease, so that you can focus on growth.
AI-powered search finds the right regulations instantly with no manual filtering.
Effortlessly manage submissions, and approvals in one place.
Generate compliance reports in seconds, without manual work or delays.
Centralized document tracking ensures nothing slips through the cracks.
Built for regulatory teams and consultants to scale faster without the compliance slowdowns.
Maximize efficiency, reduce idle time, and fast-track approvals.
Automate compliance tracking, approvals, and regulatory updates in one place.
Eliminate inefficiencies with AI-powered workflows that minimize manual processes.
Fast-track audits and reduce delays with real-time compliance accuracy.
Centralized compliance hub with built-in task management.
Built for auditing organizations and compliance teams looking to accelerate approvals and scale their certification processes.
At this time, all tools are available for free!
All searches are specific to the authenticated user. We rely on an external SOC2-certified authentication platform to ensure that we never retain user names or passwords.
Use the Contact Us area at the bottom of the page to let us know about it!
All data is retrieved from publicly available regulatory authority repositories - updated at least monthly. Feel free to Contact Us if you have more questions.
