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...
In today’s rapidly evolving regulatory landscape, medical device companies face increasingly complex challenges in bringing their products to market and maintaining compliance across multiple jurisdictions. The good news is that technological advancements, particularly in artificial intelligence (AI), machine learning (ML), and automation, are revolutionizing the field of regulatory affairs. These innovations are not just buzzwords; they’re powerful tools that can streamline workflows, reduce errors, and significantly accelerate time-to-market for medical devices.
The new article describes in detail certain specific aspects to be taken into consideration by the parties involved in order to ensure the important information is duly communicated in accordance with the relevant regulatory requirements.
The article describes in detail the approach the UK authority intends to apply when implementing amendments to the existing legal framework.
The new article provides additional clarifications regarding the upcoming changes to the UK regulatory framework.
The article outlines the key points of the regulatory approach applied in Tanzania when it comes to medical devices intended to be marketed and used in the country.
The new article explains in detail the way the relevant principles and practices should be implemented in order to ensure the safety and proper performance of medical devices allowed for marketing and use in the country.
The new article provides additional details and extensive clarifications regarding the approach to the regulation of medical devices and diagnostic products.
The new article provides additional clarifications regarding the specific scope of information-related obligations medical device manufacturers should comply with.
The article highlights the key points related to the manufacturers’ obligations in case of product supply being interrupted or discontinued.
