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.

HSA on advertising (overview)

HSA Guidance on Advertisement Controls of Health Products: Overview

by | May 28, 2024 | HSA,Singapore | 0 Comments

The article provides a general overview of the existing legal framework for advertising healthcare products allowed for marketing and use in Singapore.

HSA on advertising (key aspects)

HSA Guidance on Advertisement Controls of Health Products: Key Aspects

by | May 28, 2024 | HSA,Singapore | 0 Comments

The new article describes in detail the key aspects related to the advertising activities in the context of medical devices intended to be marketed in Singapore.

FDA on tissue heating cooling devices (testing methodology)

FDA Guidance on Tissue Heating/Cooling Devices: Testing Methodology

by | May 22, 2024 | FDA,United States | 0 Comments

The new article provides additional clarifications regarding various testing methodologies to be used when assessing the thermal effect caused by medical devices when used for the intended purpose, as well as the risks associated with it.

FDA on tissue heating cooling devices (specific aspects)

FDA Guidance on Tissue Heating/Cooling Devices: Specific Aspects

by | May 22, 2024 | FDA,United States | 0 Comments

The new article outlines specific aspects associated with the evaluation of medical devices impacting the tissue temperature including, inter alia, the ones related to computational modeling as one of the assessment methods to be used.

HSA on product registration submission

HSA Guidance on Product Registration Submission

by | May 22, 2024 | HSA,Singapore | 0 Comments

The article provides a general overview of the regulatory framework for product registration submissions, including the relevant procedures for applying for marketing approval in Singapore.

Turkish guidance on calibration and testing

Turkish Revised Guidance on Testing, Control, and Calibration Activities: Overview

by | May 22, 2024 | TMMDA,Turkey | 0 Comments

The article highlights the critical points related to the legal framework for medical device testing, control, and calibration.

TGA on recalls (overview)

TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Overview

by | May 20, 2024 | Australia,TGA | 0 Comments

The article describes the recall procedures to ensure the continued safety of medical devices and other therapeutic products allowed for marketing and use in Australia.

TGA on recalls (step 1-3)

TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Steps 1-3

by | May 20, 2024 | Australia,TGA | 0 Comments

The new article describes in detail the first three steps of a recall process, which include obtaining information and distribution status, conducting a risk analysis, and deciding on the type, class, and level of recall.

TGA on recalls (step 4-7)

TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Steps 4-7

by | May 20, 2024 | Australia,TGA | 0 Comments

The new article provides additional details regarding the subsequent steps of the recall process, including the development of an action strategy, drafting a communication strategy to be followed when conducting a recall, and also the matters related to interactions with the authority, such as the noes associated with the submission of the relevant notification and an assessment to be conducted by the TGA