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Alex Cadotte, PhD

VP, Digital Health, AI, and Radiology
MCRA, and IQVIA company
Washington, District of Columbia

Dr. Cadotte specializes in FDA interactions and strategy, development of regulatory submissions, medical and regulatory writing, review and analysis of pre-clinical and clinical data, design of clinical trials, regulatory review of marketing materials, and regulatory strategy for medical devices. He specializes in medical device software, Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), Artificial Intelligence / Machine Learning (AI/ML) devices, Clinical Decision Support, Predetermined Change Control Plans, and Computer Aided Devices including Triage, Notification, Detection, and Diagnosis (CADt, CADe, CADx, and CADe/x).

Disclosure information not submitted.

Presentation(s):