
Ellie Reynolds
Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research
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Nov 2, 2023 • 39min
#342: Planning an FDA Submission
Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, shares insights on FDA submissions for medical devices. She discusses different submission types, early FDA interactions, eSTAR system, and building relationships with review teams. Reynolds emphasizes preparation, organization, and proactive engagement with regulatory bodies for successful submissions.