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.
Worldwide, medical devices are subject to strict regulations, and for good reason — they are crucial for helping health care professionals identify, treat and combat...
Medical devices are highly regulated in the United States. Since U.S. regulatory compliance for MedTech is stringent and continuously changing, staying up-to-date on...
Global market access is crucial for medical device companies looking to reach new customers, enhance brand recognition worldwide and ultimately increase revenue...
The article highlights the key points related to the regulatory framework for healthcare products in New Zealand
The new article describes in detail the key elements of the regulatory system for healthcare products.
The new article provides further clarifications on certain specific aspects associated with the regulatory requirements healthcare products, including medicines and medical devices, should comply with in order to be allowed for marketing and use in New Zealand.
The new article explains the approach to be applied with respect to different categories of healthcare products based on specific criteria.
The article provides a general overview of the new regulatory framework for innovative AI-based healthcare products intended to be marketed and used in the UK.
The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
The new article elaborates further on the matters related to on-site assessment activities to be undertaken in the context of the designation process.
The article provides an overview of the authorization process for clinical trials involving medical devices to be conducted in Germany.
The article describes the approach to be applied to innovative medical devices utilizing machine-learning technology.
