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.
On July 21, 2025, the Italian Ministry of Health published its long-awaited Guidelines on Healthcare Advertising for Medical Devices, consolidating and replacing previous scattered instructions into a single, authoritative reference
As software continues to transform healthcare, Software as a Medical Device (SaMD) has emerged as a powerful engine of innovation. From AI-driven diagnostic tools to mobile apps for chronic disease management, software is no longer just supporting medical devices, it is the device.
On July 23, 2025, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) published a draft regulation that, once finalized, will reshape the country’s medical device and in-vitro diagnostic (IVD) landscape
In the medical device industry, regulatory change is constant, global, and often unpredictable. A health authority may issue a revised labeling requirement, introduce new clinical evidence standards, or reclassify a device category without advance notice.
Kyrgyzstan is entering a pivotal stage in its regulatory evolution. On July 16, 2025, the Cabinet of Ministers of the Kyrgyz Republic formally adopted a set of amendments aimed at supporting the country’s transition from a national regulatory model to the unified medicines market of the Eurasian Economic Union (EAEU).
In the MedTech world, few processes are as universally dreaded as regulatory submissions. Despite advancements across R & D and commercialization, the path to regulatory approval remains bogged down by manual workflows, disconnected systems, and ever-changing global requirements.
South Korea continues to expand support for medical innovation with the latest revision to its Guidelines on Pre-Consultation for Innovative Products.
Artificial intelligence is reshaping healthcare and nowhere is this more evident than in the surge of AI-enabled medical devices transforming clinical diagnostics, personalized treatment, and patient monitoring.
On May 16, 2025, Pakistan’s Drug Regulatory Authority (DRAP) published the third edition of its Guidelines for the Conduct and Reporting of GCP Inspections, offering a more structured, risk-based, and globally harmonized framework for evaluating clinical trials.
