---
bio: "I am a quality and regulatory consultant with extensive experience supporting\
  \ startup medical device companies developing cutting-edge technologies. I have\
  \ worked across fast-paced development and commercialization environments, helping\
  \ teams implement practical, scalable quality systems and regulatory strategies\
  \ that align with FDA and ISO 13485 requirements.  \n  \nI graduated from Drexel\
  \ University with a Bachelor's degree in Biomedical Engineering and a minor in Neuroscience.\
  \ I am particularly interested in innovative medical device and digital health technologies\
  \ and enjoy working on a wide variety of projects that bridge engineering, quality,\
  \ and regulatory strategy."
hire_date: '2026-02-23'
hobbies: Outside of work, I'm a certified yoga teacher, former competitive horseback
  rider, enthusiastic baker, and experimental home barista who loves exploring new
  restaurants and staying active.
linkedin: null
name: Maddie Tran
photo: /img/people/Maddie_Tran-303bd5b7a7548056a8d8ce5714c21046.jpg
skills: ISO 13485 Lead Auditor; IEC 62304 Certified. Experience supporting compliance
  with FDA 21 CFR Part 820 (QSR/QMSR), ISO 14971, IEC 62366-1, and FDA SaMD guidance.
testimonials: []
title: Associate Quality/Regulatory Consultant
---