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Seyed Kahaki

Seyed Kahaki

Senior Research Scientist and Regulatory Reviewer

Healthcare

Middletown, Frederick

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About Seyed Kahaki:

I am an AI/ML Research Scientist at the FDA with over eight years of experience in medical image analysis, regulatory science, and Software as a Medical Device (SaMD). My expertise spans AI/ML, digital pathology, and regulatory evaluations, ensuring AI-driven healthcare solutions are innovative and compliant with safety standards.

At the FDA, I have conducted regulatory reviews for AI-enabled medical devices, including 510(k), De Novo, and breakthrough applications. My research at Harvard Medical School and Dana-Farber Cancer Institute strengthened my skills in medical imaging, data quality assurance, and AI model validation. I have developed open-source tools like ValidPath and ClearData to enhance data quality and AI transparency in digital pathology.

With a Ph.D. in Computer Science and expertise in Python, SQL, and Power BI, I combine data science, software development, and regulatory knowledge to drive AI innovation in healthcare. I am passionate about advancing AI-powered solutions that improve patient outcomes while ensuring regulatory compliance.

Experience

I am an AI/ML Research Scientist at the FDA with over eight years of experience in medical image analysis, regulatory science, and Software as a Medical Device (SaMD). My expertise spans AI/ML, digital pathology, and regulatory evaluations, ensuring AI-driven healthcare solutions are innovative and compliant with safety standards.

 

Education

With a Ph.D. in Computer Science and expertise in Python, SQL, and Power BI, I combine data science, software development, and regulatory knowledge to drive AI innovation in healthcare. I am passionate about advancing AI-powered solutions that improve patient outcomes while ensuring regulatory compliance.

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