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 associated with the regulatory status of certain products placed on the EU market and also describes in detail the approach to be applied with respect to qualification.
The new article outlines specific aspects associated with the registration of medical devices intended to be marketed and used in Singapore, emphasizing the most essential matters to be considered to ensure compliance with the requirements set forth under the existing legal framework.
The article highlights the critical points associated with the regulatory framework for surgical sutures intended to be marketed and used in Saudi Arabia.
The article provides a general overview of the regulatory requirements for medical devices developed by healthcare institutions to meet their internal needs.
The new article highlights the critical points associated with the concept of intended use and clarifies the approach to be applied concerning risks associated with in-house medical devices.
The new article describes in detail the authority’s review process when assessing applications related to medical devices.
The new article describes in detail the regulatory approach to be followed concerning the manufacturing process, post-market surveillance, and other aspects.
The article provides a general overview of the key terms and concepts used in adverse event reporting related to medical devices.
The new article describes the key terms and concepts used in adverse event reporting for medical devices.
