Our Story

Our story began with one simple question: what would the world be like if most new medical device technology wasn’t stuck in regulatory limbo? In 2014, RegDesk Founder and CEO Priya Paul sought to answer that question.

Priya envisioned a single software platform that consolidates every step of the regulatory approval process, from initial intelligence gathering to application building and beyond.

From the start, the ambitious project attracted support from industry experts. DreamIt Health Philadelphia saw promise in the platform and provided funding to get the project off the ground in 2015. Since then, RegDesk has helped companies big and small get their devices to market faster and stay on the market longer.

RegDesk is a certified Minority Business Enterprise (MBE) with the National Minority Supplier
Development Council (NMSDC).

We are aligned with medical device companies in their mission to expedite access to medical and diagnostic products to patients worldwide. Our AI-enabled regulatory compliance platform is an attestation to that commitment.

– Priya Paul
Founder & CEO, RegDesk

OUR VALUES

Valuable Impact

Customer Obsession

Constant Innovation

Ethical Collaboration

OUR LEADERSHIP

Jixian Wang

CTO

Priya Paul

Founder & CEO

Dan Piscatelli

CFO

RegDesk Regulatory Roundup

Never miss a thing in the world of medical device regulatory compliance. The latest regulatory news and updates are always on our feed.

Navigating Global Regulations for Software as a Medical Device (SaMD)

Navigating Global Regulations for Software as a Medical Device (SaMD)

by | May 7, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

Software as a Medical Device (SaMD) is transforming the future of healthcare, enabling innovative diagnostics, real-time patient monitoring, and advanced clinical decision support.

ANSM Notice on Updated Medical Device Framework

ANSM Notice on Updated Medical Device Framework

by | May 5, 2025 | ANSM, EUDAMED, European Union, France | 0 Comments

The article provides a general overview of the regulatory requirements for medical devices intended to be marketed and used in France

Navigating the FDA Medical Device Approval Process: A Step-by-Step Guide for Manufacturers

Navigating the FDA Medical Device Approval Process: A Step-by-Step Guide for Manufacturers

by | Apr 30, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

Gaining FDA approval is a pivotal milestone for any medical device manufacturer seeking to enter the U.S. market.

Navigating the Medical Device Approval Process

Navigating the Medical Device Approval Process: A Global Overview

by | Apr 23, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

Entering the global medical device market is a complex journey that requires a deep understanding of diverse regulatory landscapes. From the United States to Japan, each country has its own set of rules, timelines, and expectations. 

Australia Complying with UDI timeframes

TGA Guidance on UDI Timeframes

by | Apr 22, 2025 | Australia, AusUDID, EU MDD, TGA | 0 Comments

The document provides an overview of the applicable regulatory requirements in the sphere of unique device identification.

Impact of FDA Staff Cuts on Patient Access to Medical Devices

Impact of FDA Staff Cuts on Patient Access to Medical Devices

by | Apr 17, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

Jodi Granger is the Director of Regulatory Affairs at RegDesk. ​

Navigating ISO 13485 Compliance with RegDesk

Navigating ISO 13485 Compliance with RegDesk

by | Apr 16, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

In the highly regulated medical device industry, quality and compliance are non-negotiable. ISO 13485, the international standard for Quality Management Systems (QMS) in the medical device industry, plays a critical role in ensuring that manufacturers meet regulatory requirements for medical devices and in-vitro diagnostic products. 

Saudi Arabia MDS G26 Guidance on Comparison Diagnostic IVDs

SFDA Guidance on Companion Diagnostic IVDs

by | Apr 15, 2025 | KSA, Saudi Arabia, SFDA | 0 Comments

The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to companion diagnostic IVDs

Ensuring Compliance with Medical Device Packaging Validation Regulations

Ensuring Compliance with Medical Device Packaging Validation Regulations

by | Apr 10, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

Packaging validation is a critical component of ensuring the safety, sterility, and integrity of medical devices.