"If we can save one life, it's worth it."
- Priya Bhutani, Founder/CEO, Regdesk
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 Bhutani sought to answer that question.
Bhutani 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).
Our Values
Valuable impact
Customer Obsession
Constant innovation
Ethical Collaboration
Our Leadership
Our Advisory Board
Our Regulatory Blog
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TGA Guidance on Certificates of Free Sale and Export Certificates
Jun 2, 2021
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices,
has published guidance dedicated to certificates of free sale and export certificates.
The document describes in detail the eligibility criteria and how...
FDA on Investigational Device Exemptions for Early Feasibility Studies
Jun 2, 2021
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to investigational device exemptions (IDEs) for early feasibility medical device clinical studies. The scope...
Health Canada Guidance on Applying for an MDEL
Jun 2, 2021
Health Canada, the Canadian regulating authority in the sphere of medical devices, has published a guidance document describing the most important aspects
related to the medical device establishment license (MDEL),
special permission necessary to carry out the...
TGA Guidance on Certificates of Free Sale and Export Certificates
Jun 2, 2021 Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published guidance dedicated to certificates of free sale and export certificates. The document describes in detail the eligibility criteria and how...
