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.
Gaining FDA approval is a pivotal milestone for any medical device manufacturer seeking to enter the U.S. market.
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.
The document provides an overview of the applicable regulatory requirements in the sphere of unique device identification.
Jodi Granger is the Director of Regulatory Affairs at RegDesk.
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.
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
Packaging validation is a critical component of ensuring the safety, sterility, and integrity of medical devices.
The new article provides clarifications regarding the transitional arrangements associated with the changes in the legal framework.
Mastering regulatory change management is crucial for medical device companies to stay compliant and competitive in a rapidly evolving regulatory environment.
