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Effortless 510(k) Compliance for Early- Stage Innovators

Streamline your regulatory journey with AI-powered 510(k) reports and expert insights tailored for med-tech startups.

We Are Visionaries

Empowering medical device startups with cutting-edge AI technologies to provide grounded insights for faster, more efficient market access.

We support startups through all stages of their regulatory life cycle, guiding users through ISO, FDA, HIPAA, GDPR, MDR compliance, and more. 

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Custom Solutions for Startups, from Ideation to Approval

Research & Technology

Veridocx assists in early stages of regulatory compliance by providing real-time guidance, classifying medical devices, strategic roadmap and offering tailored feedback. 

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1

Up-To-Date Data

COMPREHENSIVE EXPERTISE

We ensure that our algorithm is always informed on the newest regulatory changes.

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2

Human Evaluation

COMPREHENSIVE EXPERTISE

All chatbot outputs are human reviewed by regulatory professionals to ensure accuracy.

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Transformative Impact

COMPREHENSIVE EXPERTISE

We make 510(k) approval more accessible by providing affordable, detailed reports and actionable feedback, helping startups move quickly from concept to market.

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Built for the Earliest Stages of 510(k) Approval

From classification to pre-submission preparation, Veridocx supports you every step of the way.

What We Do

  • Classify devices under CFR Title 21.

  • Identify predicate devices to streamline submission.

  • Generate pre-submission preparation guides.

 
Tech-Driven Insights

  • Our algorithm identifies key regulatory requirements and guides you in structuring your 510(k) submission, ensuring you’re ready for FDA review.

 
Real-Time Feedback

  • Get immediate answers and actionable feedback on your regulatory strategy, all backed by our proprietary AI technology.

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Image by Ilya Pavlov

Ageless Advisors in Numbers

3

Universities Affiliated

24/7

Support

<60

Regulatory Insights in less than 60 seconds

100%

Focus on startups

50%

Up to 50% less than a traditional firm

Why Choose Veridocx?

Early-stage companies often lack the resources or expertise to navigate 510(k) compliance. Veridocx bridges that gap by providing actionable, cost-effective solutions powered by AI and enhanced by human expertise. From understanding CFR 21 regulations to creating structured 510(k) reports, we’re here to help you succeed.

Affordable For Startups
  • Up to 50% more affordable than traditional consulting firms.
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Human Review
  • Every report is validated by certified regulatory professionals.
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Comprehensive Data Backing
  • Built on FDA, CFR Title 21 compliance data and predicate databases.
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Transformative Results
  • Accelerate your submission process by weeks with actionable, AI-generated insights.
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Ready to Get FDA Approval?

How does the process work?

Reach out to us for a free demo and sign up for early access!

What industries do you serve?

We work with companies that fall under medical device, SiMD, and SaMD designations.

How long does a typical engagement last?

We are an end-to-end tool for FDA submissions but flexible payment models allow you to use our services on an as-needed basis.

Start Your 510(k) Journey Today 

Contact us to learn how Veridocx can simplify your path to FDA approval. 

We would love to hear your feedback! 

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