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 Grouping of Medical Devices: Overview
Mar 13, 2022
The first article provides a brief overview of the general rules for grouping medical devices when applying for marketing approval in Singapore...
FDA Guidance on IDEs for Early Feasibility Studies: an Overview
Mar 12, 2022
The present article provides a brief overview of the existing regulatory framework in the sphere of investigational device exemptions and describes special pathways to be applied to ensure the availability of novel medical devices.
SAHPRA Guidance on Medical Device Establishment License Renewal
Mar 11, 2022
The article describes in detail the regulatory requirements related to the procedure of medical device establishment license renewal in South Africa based on the respective documents.
EFDA Guidelines for Marketing Authorization of Medical Devices...
Mar 10, 2022
The present article describes in detail the aspects related to the Ethiopian classification rules for both general and in vitro diagnostic medical devices, as well as the criteria for medical devices grouping when applying for marketing authorization.
FDA Guidance on Human Factors and Usability Engineering: Formative Evaluation
Mar 10, 2022
The new article addresses specific factors related to empirical analysis (formative evaluation). Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
