Medical Devices
At IUVO Consulting, LLC, we specialize in 510(k) submissions and comprehensive FDA regulatory services for medical devices. With nearly 100 clearances under our belt, we provide expert guidance on 510(k), De Novo, IDE, registration, labeling compliance, and more—streamlining your path to market.
In Medical Device Compliance
We are 510(k) Specialists
When it comes to FDA clearance for medical devices, experience matters—and at IUVO Consulting, LLC, we are 510(k) specialists. With nearly 100 devices successfully cleared, we know exactly what it takes to navigate the FDA process quickly and efficiently. Whether you need a 510(k), De Novo submission, IDE, or site registration, we streamline compliance so you can get your device to market faster.
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Specialists in FDA 510(k) Submissions: Nearly 100 devices successfully cleared, ensuring fast and efficient navigation through the FDA process.
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Comprehensive Regulatory Support: From 510(k) and De Novo submissions to IDE and site registration—we streamline compliance to accelerate your time to market.
IUVO Consulting
Medical Device Regulatory Services
510(k) & De Novo Submissions
End-to-end guidance to ensure your device meets FDA clearance requirements.
513(g)
Requests
Gain clarity on your device classification and regulatory requirements.
Annual Registration & Device Listing
Strategic We manage your establishment registration and device listings to keep you in compliance.for emerging companies
U.S.
Agent Services
Non-U.S. companies rely on us as their official FDA liaison.
Pre-Submission Meetings
Engage with the FDA early to avoid surprises and increase approval success.
Labeling
Compliance
Ensure your device labeling, marketing materials, and packaging meet FDA regulations.
Expert Regulatory Guidance for Medical Devices
Discover how our team can help you develop and implement a successful regulatory strategy to bring your medical device to market with confidence.