The Platform for

Integrated Complaint Management and Post-Market Surveillance

with Human-Centered AI

Empowering Regulatory and Quality professionals with a compliance platform built to turn post-market chaos into strategic advantage—so teams stay ahead of risk, not buried under it.

Automate complaint triage, risk harmonization, and PMS workflows with Empowerreg—the integrated CMPMS™ built for modern regulatory teams.

Redefining Global Compliance—One Workflow at a Time

AI-Native Compliance for the Total Product Lifecycle

Legacy tools were never designed for today’s post-market complexity. We built EmpowerReg from the ground up with a different mindset—AI-native and purpose-built for total product lifecycle compliance.

AI-Native from Day One

EmpowerReg isn’t retrofitted with AI—it’s built on it. That means smarter automation, faster insights, and continuous learning across your compliance ecosystem.

End-to-End Integration

From intake to reporting, complaints to vigilance, EmpowerReg connects your post-market workflows into one seamless, regulation-aware system. No more swivel chair operations.

Unified Risk Intelligence

We bring public and private data—complaints, user feedback, adverse events, serious incidents, even clinical results—into one platform. Each signal is tied to the product and its risks, powering a dynamic risk profile that supports proactive action, not reactive fire drills.

Built by Experts, for Experts

Created by regulatory professionals, data scientists, and MedTech veterans, EmpowerReg is purpose-built to meet the real challenges compliance teams face every day.

Designed to Scale Globally

Whether you’re launching in the U.S., EU, or emerging markets, EmpowerReg evolves with global standards—keeping your teams compliant and competitive.

The Solution for A Growing Burden

in Regulatory Compliance

“Compliance shouldn’t slow you down. It should speed you up—while keeping patients safe and regulators aligned.”

Smart Data Architecture

Bringing Diverse Data at your fingertips. Combine private and public data at will and unleash the power of our platform to enhance your Signal Detection Capabilities.

Complaint Management

Bringing Complaints, Reportability-Automation with Human-in-the-loop, vigilance data and risk under a common Umbrella

Product Hub

Centralized Hub for all your Product and Market related data supported by our Automated integration with registration databases.

InteliRisk™

AI-powered Risk analysis of Complaints, Clinical feedback, and Adverse Events.

Smart Viz and Monitoring

Focused postmarket insights with filtering, visualization, and trend detection

empowerNinja

Our platform comes bundled with our ninjas who have deep regulatory and quality experience across a wide range of medical device and IVD companies. They get your job done!

Plugging the Gap in Your Compliance Stack

Compliance = Your QMS + Our CMPMS™

Why Empowerreg?

Regulatory Compliance & Risk Management

Market Access & Growth Acceleration

Our Industry Focus

Medical Device
Manufacturers

In Vitro Diagnostic
Manufacturers

Regulatory & Quality
Consultants

Engineering Design
Firms

Medical Device &
IVD Startups

Innovation Incubators, Research
Centers, and Law Firms

Our Customers

and Strategic Partners

Hear what our clients say

About Us

At empowerreg.ai, we are dedicated to overcoming the significant challenges of regulatory processes through technology. Our platform is more than a collection of tool; it’s a beacon for firms navigating the complexities of global regulatory landscapes. By integrating deep regulatory expertise with technology, we help our clients transform data into strategic assets, making compliance a gateway to innovation rather than a barrier

Surya Pathak

CEO and Founder
Professor at University of Washington, School of Business, Former CEO, CQUESTIP

An UW distinguished award winner researcher with extensive publications, and a deep consulting background, Surya brings unparalleled academic prowess and deep industry experience to propel innovation at empowerreg.

Sayan Pathak

Founder & Chief Scientific Advisor
Adjunct Faculty UW and IIT Kharagpur

With 25 USPTO patents, first to get an FDA approved software platform for health within Microsoft, managing the Azure Open AI stack, the creation of the first Mouse-Brain Atlas, and over $5M raised in government grants, Sayan brings a powerful combination of groundbreaking innovation, domain expertise, and fundraising success.

Christine Zomorodian

Chief Regulatory Intelligence Officer & Founding Member
Founder and CEO, Gish Consulting LLC

With an MS in Biomedical Regulatory Affairs and 35 years across life sciences, healthcare, medtech, and software, Christine brings deep domain expertise with a proven record of predictive insight and innovation. She built Microsoft Health’s QMS, developed breakthrough clinical bioassays, earned five corporate excellence awards, and lectures regularly to students and industry.

Angshuman Guha

CTO & Founding Member
Former Founder and CTO of Bipp AI

With 24 USPTO patents in machine learning, a successful exit from Bipp.io (an AI/ML company), multiple gold medals in Computer Science & Engineering, and leadership expertise at the top software firms including Microsoft and Google, Angshuman brings a powerful blend of deep technical innovation, enterprise-grade engineering, and entrepreneurial success.

We’ve Reached a Milestone: Successful First Round of Funding!

We are thrilled to announce that we have successfully completed our first round of funding. We extend our heartfelt gratitude to our initial set of investors for believing in the power of our platform and supporting our mission. Your confidence and support are pivotal as we continue to innovate and drive forward in our journey to transform regulatory and data management processes.

Thank you for being a part of our story!