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.
In the ever-evolving world of medical devices, staying ahead of regulatory changes is crucial for success. Throughout 2024 and into 2025, the global regulatory landscape will continue to transform at an unprecedented pace. This comprehensive guide offers a roadmap for medical device companies to navigate these changes, focusing on key regions, including the US, EU, LATAM, MENA, and APAC.
In today’s rapidly evolving regulatory landscape, medical device companies face increasingly complex challenges in managing compliance and bringing their products to market efficiently. As a regulatory professional, you’re likely all too familiar with the time-consuming and intricate process of preparing regulatory submissions. The use of AI streamlines this process to reduce errors, improve compliance and get your product to market faster.
The article provides a general overview of the regulatory approach to be applied with respect to corrective actions.
The new article further elaborates on the most crucial aspects related to corrective and preventative actions to be taken by the parties responsible for medical devices in order to ensure continued safety and proper performance.
The new article pays special attention to the role of the key parties involved.
The article provides a brief overview of the applicable regulatory requirements set forth under the existing legal framework.
The new article describes in detail the applicable performance criteria to be taken into consideration by the parties responsible for medical devices covered by the scope of the guidance in order to ensure continued safety and proper performance of the latter.
The article provides a general overview of the electronic reporting requirements in Pakistan.
The new article describes in detail the approach to be applied when it comes to content development.
