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 article highlights the key points related to the regulatory status of legacy devices.
The new article provides additional clarifications regarding specific aspects of the regulatory approach to be followed.
The article provides a general overview of the applicable regulatory requirements and highlights the key points associated thereto.
The new article describes in detail certain specific aspects related to the regulatory status of endosseous dental implants and performance criteria they should meet in order to be allowed for marketing and use in the US.
In today’s rapidly evolving healthcare landscape, medical device manufacturers face the dual challenge of driving innovation while ensuring regulatory compliance. As connected devices become increasingly prevalent, cybersecurity has become a critical concern in regulatory submission.
The new article provides a detailed overview of certain specific regulatory aspects associated with x-ray devices intended to be marketed and used in the US.
The new article provides extensive clarifications on labeling requirements to be followed in order to ensure all the vitally important information is duly communicated to end-users.
The new article clarifies the requirements pertaining to the date of manufacture and also highlights the measurement-related matters.
The document provides an overview of the EtO regulatory status and highlights the key points to be taken into consideration by the medical device manufacturers utilizing it in their processes.
