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.
The European Commission’s Health Technology Assessment Regulation (HTAR) marks a significant step toward harmonizing health technology evaluations across EU member states.
This article provides key insights to navigating China’s complex medical device regulatory landscape.
The article highlights the key points related to the UK regulatory framework for clinical investigations involving medical devices.
This article provides key insights to navigating China’s complex medical device regulatory landscape.
This article outlines the key steps and practices to ensure effective cybersecurity protocols.
The article provides a general overview of the EU vigilance regulatory framework.
In the rapidly evolving world of medical devices, keeping pace with regulatory changes is essential for success. As the global regulatory landscape undergoes significant transformation through 2024 and 2025, this comprehensive guide serves as a vital resource for medical device companies.
The article describes in detail the recent regulatory updates pertaining to medical device registration procedures in Taiwan.
The document provides an overview of the existing legal framework for innovative medical devices intended to be marketed and used in Korea.
