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Yujan Shrestha, MDMay 3, 2024 1:00:24 PM5 min read

How to FDA Approve LLMs. Step 1 Presubmission.

Who is this for? If you landed on this page, you're probably interested in applying large ...

Yujan Shrestha, MDApr 27, 2024 3:18:30 PM3 min read

User Needs vs. Requirements for Software as a Medical Device

I often get questions about the difference between user needs and requirements. ...