How US-certified and European Radiologists Shape AI Development

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July 10, 2025 | 6 min read

medDARE’s Head of Operations, Natalia Kharkova, emphasizes that aligning annotation processes with both clinical standards and regulatory expectations is essential for delivering reliable AI outcomes.

The future of medical AI depends on clinical confidence—and that confidence starts at the data level, with every image, every annotation, and every expert review. Working with US-certified and European radiologists is not just a value-add; it’s a necessity for companies building AI solutions for a global healthcare ecosystem. 

medDARE’s Head of Operations, Natalia Kharkova, emphasizes that aligning annotation processes with both clinical standards and regulatory expectations is essential for delivering reliable AI outcomes. At medDARE, we’re proud to support AI innovators with datasets that meet the highest standards of accuracy, compliance, and trust.

Why Accuracy in Medical Data Is Critical

Medical AI models are only as good as the data they are trained on. In radiology, this means:

  • Precise annotations (e.g., lesion boundaries, tumor contours)
  • Correct clinical labeling (e.g., diagnoses, classifications)
  • Consistent standards across datasets and modalities

A small error in annotation can lead to significant downstream consequences in model training and clinical use. For example, mislabeling a benign mass as malignant could cause AI to overdiagnose, increasing false positives and undermining trust.

The Role of Radiologists in Annotation

Accurate annotation in radiology is not a task for generalists or automated tools alone—it requires deep clinical knowledge. Radiologists bring:

  • Anatomical precision: Identifying subtle differences across patients and modalities
  • Diagnostic context: Understanding how imaging correlates with clinical findings
  • Experience with edge cases: Recognizing rare or complex patterns that AI needs to learn from

This is why medDARE works directly with licensed, experienced radiologists in both the United States and Europe to label datasets for training and validating AI models. In fact, we collaborate with over 100 radiologists on both sides of the Atlantic to successfully deliver our projects for clients across Europe and North America.

US-Certified vs. European Radiologists: Complementary Perspectives

By collaborating with American and European radiologists, we’re able to deliver datasets that meet diverse regulatory and clinical expectations. Here’s how these roles complement each other:

  • US-Certified Radiologists
    • Ensure alignment with FDA requirements
    • Support clients developing software for the American healthcare market
    • Offer familiarity with US imaging protocols and clinical practices
  • European Radiologists
    • Provide compliance with European regulations and MDR standards
    • Bring regional diversity in imaging, reporting, and case distribution
    • Being more price competitive on the data annotation market

Together, these experts help us build global-grade datasets that are robust, compliant, and ready for real-world deployment.

medDARE’s Approach to Quality and Accuracy

As a healthcare-focused data collection and annotation company, medDARE ensures quality through:

  • Dedicated teams of radiologists for every project
  • Clinical onboarding and regular QC rounds by modality experts
  • Compliance with ISO 9001, 27001, and 37001 for quality, information security, and ethics

We understand that building AI for radiology isn’t just about data volume—it’s about data you can trust.

Final Thoughts: Building Trust in AI Starts with Trust in Data

The future of medical AI depends on clinical confidence. Working with US-certified and European radiologists is not just a value-add; it’s a necessity for companies building AI solutions for a global healthcare ecosystem.

At medDARE, we’re proud to support AI innovators with datasets that meet the highest standards of clinical accuracy, regulatory compliance, and ethical data stewardship.

Need high-quality annotated data for your next AI project?
Let’s talk. Whether you’re building for FDA approval or EU deployment, our radiologist-led workflows ensure your data works as hard as your algorithms.

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