Profile

Username

ckangmedtegrityrq

First Name

Catherine

Last Name

Kang

Title

CEO and Founder/Consultant

Location

Chicago, IL, USA

Company Name

MedTegrity RQ LLC

Professional Bio/Service Description

With a PhD in Chemical Engineering and Applied Chemistry from the University of Toronto—earned through a collaborative program with the Institute of Biomaterials and Biomedical Engineering—I’ve dedicated my career to bridging science, regulation, and innovation. I also hold a Master’s and Bachelor’s in Bioengineering from the University of Illinois at Chicago, with concentrations in cell and tissue engineering, and neural engineering, respectively. My research has explored everything from neuroprotective drug delivery and spinal cord injury repair to cellular alignment and polymer science, resulting in numerous peer-reviewed publications and a patent.

Over the past two decades, I’ve held leadership roles in global regulatory affairs for combination products, medical devices, and pharmaceuticals. I’ve supported companies through device and drug premarket submissions, preparation of CMC documentation, global registration strategies, clinical regulatory strategies, DHF remediations, Quality Management System development and optimization, and product lifecycle management. My work has touched every stage of product development—from concept to market launch—at large and small organizations and as a consultant. I formed MedTegrity RQ in 2025 with the intent to help MedTech companies navigate the complex intersection of innovation and compliance with integrity, clarity, and creativity.

MedTegrity RQ was born from a belief that regulatory work can be both rigorous and imaginative. I built this company for clients who value diligence, depth, and a human-centered partnership—and for those who are trying to make a meaningful impact in healthcare.

Your Website

medtegrityrq.com

LinkedIn URL

http://www.linkedin.com/in/catherineekang

Languages

English

Expertise

Business Pitch

I don't have a pitch yet

Years of MedTech Experience

22

Licenses and Certifications

N/A

Areas of Expertise

Quality Assurance, Regulatory Affairs, Medical Device Testing, Product Development, Documentation & SOPs

Regions of Expertise

United States (US), European Union (EU), Canada, United Kingdom (UK), Australia

Hourly Rate (Range)

Contact for Details

Service Provided

Consulting

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