We have decades of collective experience and bring an engineering, clinical, and FDA regulatory skillset to your team.
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.
Writing about AI/ML in medical devices, playing with my son, snowboarding, video games, playing the Ukulele
I help bring high-impact diagnostic medical devices onto the US market. I’ve helped develop over 35 diagnostic devices since 2012. I provide a pragmatic, cross-functional perspective, with a background in biomedical engineering, software development, and FDA regulatory consulting. I run Innolitics with Yujan, my old friend and business partner.
I enjoy reading, thinking, and writing about classic literature, philosophy, history, and religion. My personal website is goodlifeodyssey.com.
DIRECTOR OF REGULATORY AFFAIRS
Joined: April 29, 2024
I am a Medical Device Quality and Regulatory Affairs consultant with a history of working on diverse products within the...
DIRECTOR OF ADMIN/FINANCE
Joined: January 20, 2023
I'm a general and theoretical physicist with three years of experience as an expert associate for physics in EdTech companies,...
DIRECTOR OF ENGINEERING
Joined: May 26, 2016
I am a biomedical engineer with 9 years of experience in software development. I’m passionate about building safe, effective, and...
SENIOR SOFTWARE ENGINEER I
Joined: June 15, 2022
I am a software engineer with 10 years of experience developing medical image processing software. I have experience with DICOM,...
SENIOR SOFTWARE ENGINEER II
Joined: January 10, 2022
I’m as full-stack software engineer with experience in medical and aerospace industries. I enjoy learning and solving problems.
SENIOR SOFTWARE ENGINEER II
Joined: April 10, 2023
I am an AI/ML Software Engineer specializing in the medical field. My expertise lies in developing and implementing AI/ML algorithms...
SENIOR SOFTWARE ENGINEER II
Joined: October 7, 2024
Kris Huang, MD, PhD, is a physician and biomedical engineer with extensive experience in medical device software development and regulatory...
SENIOR SOFTWARE ENGINEER II
Joined: September 11, 2023
I’m a software engineer with expertise in machine learning, image processing and analysis, mathematics, and data engineering. Prior to my...
SENIOR SOFTWARE ENGINEER I
Joined: September 16, 2024
I am a biomedical engineer who has worked across diverse software domains such as network traffic optimizers, 4D image acquisition/analysis...
SENIOR SOFTWARE ENGINEER I
Joined: September 20, 2021
I am a software engineer specializing in Matlab and Python code, as well as Graphical User Interface coding. I have...
SENIOR REGULATORY AFFAIRS PROJECT MANAGER
Joined: July 10, 2024
I am a certified medical device professional with over 30 years experience. I have successfully achieved almost 70 FDA 510(k)...
SENIOR REGULATORY AFFAIRS PROJECT MANAGER
Joined: September 19, 2022
I see myself as a husband, father and friend. I have been married for 30 years to my best friend’s...
REGULATORY AFFAIRS PROJECT MANAGER
Joined: February 13, 2023
I'm a biomedical engineer and regulatory professional. My journey began in a medical device startup, where I got to wear...
ADMIN ASSISTANT
Joined: October 30, 2024
I’m a mathematician with five years of experience in operations and administrative assistance, complemented by a strong passion for organization...
ASSOCIATE QUALITY/REGULATORY CONSULTANT
Joined: August 18, 2025
My name is Ameera Roubi and I graduated from the University of Texas at Austin with a degree in Biomedical...
SALES MANAGER
Joined: August 4, 2025
I’ve spent the last 5 years serving the pharmaceutical and medical device industry, aiding to the development of many lifesaving...
ASSOCIATE QUALITY/REGULATORY CONSULTANT
Joined: November 11, 2025
I am a quality, regulatory, and project management consultant with experience in various medical device industries, such as neuromonitoring, ophthalmology,...
ASSOCIATE QUALITY/REGULATORY CONSULTANT
Joined: February 23, 2026
I am a quality and regulatory consultant with extensive experience supporting startup medical device companies developing cutting-edge technologies. I have...
