Regulation Medical Device Software
Looking for a faster, more efficient way to get your medical devices to new markets? RegDesk gives you instant access to global regulatory requirements. Our application builder guides you through the submission process, and our tracking tool monitors your progress and alerts you to potential roadblocks. Our platform saves you the time and hassle of updating regulatory spreadsheets and seeking out consultants so you can focus on delivering quality products.
Our medical regulatory company offers innovative solutions that allow you to expand to any market in the world – ahead of your competitors
Get instant access to the most up-to-date regulatory requirements for more than 1000
countries
Click-through registration applications with ease with our AI-powered application
builder
Monitor the entire lifecycle of your
product from a single user-friendly
dashboard
Get instant access to or international
network of 4,000+ regulatory
experts
Join the list of industry-leading companies
who trust RegDeskTM
We can help you expand to any market in the world.
Medical device and pharmaceutical companies spend months gathering intelligence from disparate sources and preparing product registration submissions, oftentimes only to be rejected by health authorities. RegDeskTM as medical regulatory company solves that problem.
Coverage of over 100 markets and management assistance for product approvals in each and every one
Constant monitoring of global regulatory changes
.
Instant access to accurate and competitive regulatory intelligence
Utilization of artificial intelligence to deliver the most valuable and updated regulatory insights
Use of crowdsourcing to find answers to the most pressing regulatory questions
Reduce time to market and risk levels to provide advantages over competitors
Our Regulatory Blog
Never miss a thing! The latest regulatory news and updates are always on our feed.
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...
