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#342: Planning an FDA Submission

Global Medical Device Podcast powered by Greenlight Guru

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Introduction

The importance of planning the FDA submission process for medical devices is discussed, including the timing of testing and clinical trials in relation to the desired launch date. The misconception that the submission process is a simple conversation with the FDA is highlighted, emphasizing the need to clearly communicate all the work and progress done so far. Ellie Reynolds, the Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, is also introduced.

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