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.
Proactive standards tracking helps MedTech companies stay audit-ready and globally compliant
On June 17, 2025, the European Commission released a significant update to MDCG 2019-11, the foundational guidance on the Qualification and Classification of Software under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
The UK’s MHRA has issued a substantial update to its Manufacturer’s Online Reporting Environment (MORE) portal, in preparation for the Post-Market Surveillance (PMS) regulatory changes that will take effect across Great Britain on June 16, 2025.
Regulatory intelligence refers to the continuous process of gathering, analyzing, and applying regulatory information to support compliance, accelerate approvals, and guide market entry.
This article provides a detailed overview of the M11 draft which covers how clinical trial protocols are created, shared, and reviewed.
Artificial Intelligence (AI) is no longer emerging in healthcare, it’s here and it’s changing everything. From revolutionizing diagnostics to enabling real-time patient monitoring, AI is accelerating innovation across the MedTech landscape.
The article describes the approach followed by the Turkish regulating authorities in the course of harmonisation of the national legislation in the sphere of medical devices with the relevant European regulations.
The medical device industry is experiencing rapid growth and innovation. However, this process brings with it an increasing number of regulatory requirements that vary across regions and are subject to frequent changes.
The article outlines the Q-Submission process, detailing regulatory requirements, clarifications, and recommendations to help stakeholders ensure compliance.
