---
title: Resources | Yujan Shrestha, MD
description: My first SaMD FDA submission took me over a year with 3 FDA hold letters. 5 years and 10+ submission later, I can do them in 3 months or less. I made a lot of mistakes along the way. Help me help you avoid those. I have over 10 years of experience in the SaMD space as an engineer. I am a practicing AI/ML engineer and regulatory consultant with a clinical background so I can bridge knowledge gaps to help get AI/ML from concept to bedside. I enjoy working with people bringing AI/ML SaMD to market. Are you one of those people? I would love to hear your story!
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# Yujan Shrestha, MD

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My first SaMD FDA submission took me over a year with 3 FDA hold letters. 5 years and 10+ submission later, I can do them in 3 months or less. I made a lot of mistakes along the way. Help me help you avoid those. I have over 10 years of experience in the SaMD space as an engineer. I am a practicing AI/ML engineer and regulatory consultant with a clinical background so I can bridge knowledge gaps to help get AI/ML from concept to bedside. I enjoy working with people bringing AI/ML SaMD to market. Are you one of those people? I would love to hear your story!

[mailto:yshrestha@innolitics.com](mailto:yshrestha@innolitics.com)<https://www.linkedin.com/in/yujanshrestha>

## Blog Post by Yujan Shrestha, MD

## [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 ... Start Reading](https://hub.innolitics.com/blog/how-to-fda-approve-llms.-step-1-presubmission)

## [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. ... Start Reading](https://hub.innolitics.com/blog/user-needs-vs.-requirements-for-software-as-a-medical-device)

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