Yujan Shrestha

CEO, PARTNER

Joined: January 1, 2012

Skills

AI/ML Algorithms FDA

Bio

I am a physician, software engineer, AI/ML expert, and regulatory consultant. I have been developing medical device software for 10 years. I have helped startups and Fortune 500 companies write medical grade software and secure regulatory clearance. I was born in Nepal, came to the states when I was 4, and learned to code BASIC when I was 8. I graduated with a BME degree from UT Austin and a MD degree from UT Houston. I am passionate about decreasing barriers to translating medical devices from the lab to the clinic for the benefit of patients and physicians alike.

Hobbies

Snowboarding, Mountain Biking, Video Games, Ukulele, and Parrots

Articles by Yujan Shrestha

10x Coffee Talk: Threat Modeling and Cybersecurity Risk Management
FDA Grand Rounds on Synthetic Data
Coffee Time: Medical Device Cybersecurity Threats
Coffee Time: Is FDA Doing a Good Job with AI?
AI Virtual Scribes: Premarket Performance Evaluation, Risk Management, and Postmarket Performance Monitoring
FDA Strategy for Foundation Models, Gen AI, LLMs, AI Scribes, and Beyond
Open Source Radiology Foundation Models: A Comprehensive Exploration
How to Document AI/ML Algorithms in FDA Presubmissions (Q-Sub)
How to Avoid 14 Common FDA Cybersecurity Deficiencies
Foundation Models (LLM, LAM, LVM, LxM) and FDA Clearance: Best Practices, FAQs, and Presubmission Example
510(k) Preparation Pitfalls: Best Practices, FAQs, and Examples
How to Write a Medical Device User Manual
User Needs vs Requirements
Future of Generative AI in Software Medical Devices
AI/ML from Idea to FDA
Algorithm Performance Testing Intake Form
Webinar on AI/ML from Idea to FDA

Software Development

FDA Regulatory Consulting

Initial Regulatory Assessment

Regulatory Strategy

Real 510(k) Example

Fast 510(k)

Guided 510(k)

FDA Cybersecurity Remediation

Yujan Shrestha

Skills

Bio

Hobbies

Articles by Yujan Shrestha