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.

DRA on clinical research (final reporting)

DRAP Draft Guidance on Clinical Research: Final Reporting

by | Mar 14, 2024 | DRAP,Pakistan | 0 Comments

The new article describes the approach to be applied concerning reporting and record-keeping in the context of clinical investigations associated with medical devices intended to be marketed and used in Pakistan.

Health Canada on recalls (overview)

Health Canada Guidance on Medical Device Recalls: Overview

by | Mar 14, 2024 | Canada,Health Canada | 0 Comments

The article highlights the critical points related to the recall procedures applicable to medical devices allowed for marketing and use in Canada.

Health Canada on recalls (roles and responsibilites)

Health Canada Guidance on Medical Device Recalls: Roles and Responsibilities

by | Mar 14, 2024 | Canada,Health Canada | 0 Comments

The new article clarifies the recall procedure in the context of the roles and responsibilities of the parties involved.

Health Canada on recalls (process explained)

Health Canada Guidance on Medical Device Recalls: Process Explained

by | Mar 14, 2024 | Canada,Health Canada | 0 Comments

The new article describes in detail the recall process, highlighting the most important aspects associated with it.

Health Canada on recalls (reporting and terminology)

Health Canada Guidance on Medical Device Recalls: Reporting and Terminology

by | Mar 14, 2024 | Canada,Health Canada | 0 Comments

The new article clarifies the reporting requirements associated with medical device recalls and explains the key terms and concepts used in this respect.

DRAP on recalls (overview)

DRAP Guidelines on Recalls of Defective Products: Overview

by | Mar 13, 2024 | DRAP,Pakistan | 0 Comments

The article provides a general overview of the regulatory requirements for recall procedures for healthcare products intended to be marketed and used in Pakistan.

DRAP on recalls (procedure)

DRAP Guidelines on Recalls of Defective Products: Procedure

by | Mar 13, 2024 | DRAP,Pakistan | 0 Comments

The new article describes in detail the recall procedure to be followed when removing defective products from the market to ensure the safety of patients.

DRAP on recalls (responsibilities)

DRAP Guidelines on Recalls of Defective Products: Responsibilities

by | Mar 13, 2024 | DRAP,Pakistan | 0 Comments

The new article provides an overview of the critical responsibilities of the parties involved in recalls associated with therapeutic products, as well as additional communication details to ensure the vitally important safety information is duly delivered to the affected parties.

DRAP on recalls (specific aspects)

DRAP Guidelines on Recalls of Defective Products: Specific Aspects

by | Mar 13, 2024 | DRAP,Pakistan | 0 Comments

The new article highlights certain specific aspects related to the recalls the parties responsible for medical devices should initiate once it is identified that such products may pose risks to public health.