11min chapter

Think Like an Owner cover image

Rick Torres - Revolutionizing Digital Pathology at Applikate - Ep.223

Think Like an Owner

CHAPTER

Navigating FDA Approval for Digital Pathology Systems

Exploring the strategies and challenges involved in obtaining FDA approval for a digital pathology system, including the importance of a quality management system, conducting clinical trials, and justifying data convincingly within a specific time frame. Contrasting the processes of bringing drugs and software apps to market, and discussing the complexities and potential of developing hardware in the healthcare industry.

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