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
Founder & CEO
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.
The new article addresses the aspects related to the key concepts used in the context of clinical evaluation.
The new article highlights the key points related to the specific aspects of selecting proper predicates to demonstrate compliance with the applicable regulatory requirements for the medical device in question is subject to.
The document describes in detail the aspects related to the statement of positive care effect to be included in the submission.
The article provides an overview of the existing framework for electronic thermometers.
The new article highlights the aspects related to the general principles of clinical evaluation.
The new article describes in detail the enforcement policy introduced by the authority and also highlights the key points to be considered in order to comply with it.
The article highlights the aspects related to the first two methods of selecting predicates: for medical devices that are cleared based on well-established methods, and also for the products that meet or exceed the expectations.
The article highlights the aspects related to physical laboratory testing to be conducted by the parties responsible for magnetic resonance products to ensure they are safe and efficient when used for the initial intended purpose.
The article addresses the aspects related to the fees payable in the context of authorization for medical device manufacturers, wholesalers, and distributors.