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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HSA Guidance on Medical Device Product Registration: Additional Aspects
12 hours ago
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the registration of medical devices. Apart from the general requirements for registration of medical devices depending on their classes under the applicable risk-based…
FDA Guidance on Postmarket Management of Cybersecurity in ..
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 the postmarket management of cybersecurity in medical devices. The document highlights the most important aspects to be considered…
TGA Guidance on the Software for Use With COVID-19 Rapid Antigen Self-Tests: Introduction
Jun 2, 2021
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements to be applied in the case of software intended to be used with rapid antigen self-tests in the context of the outbreak of Coronavirus Disease 2019 (COVID-19) for…
FDA Guidance on Infusion Pumps: Hazard Analysis
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 infusion pumps and regulatory matters associated thereto. The document addresses the most important aspects related to the regulatory status of these products…
HSA Guidance on Medical Device Product Registration: Class C and D
Jun 2, 2021
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the procedures and processes associated with medical device product registration. The initial article on the matter describes the applicable requirements for registration of Class A and B medical…
