REGULATORY COMPLIANCE SOFTWARE
- AI Application Builder
- Regulatory Intelligence
- Change Assessment
- Standards Management
- Country-Specific Templates
- Distributor Collaboration
- AI Document Management
- Tracking & Reporting
- Alerts and Notification
- Product Management
- Claims Management
- EUDAMED
OUR CAPABILITIES
Our medical regulatory compliance software offers innovative solutions that allow you to expand to any market in the world — ahead of your competitors. Specialized pharma and medical device regulatory software helps your organization stay compliant with global and local laws and regulations while bringing a new product to market.
Regulatory Intelligence
Get instant access to the most up-to-date regulatory requirements in 120 countries
- Access comprehensive regulatory requirements for 120 markets
- Receive daily alerts on evolving changes
- Obtain timelines and costs
AI Application Builder
Click-through global applications with ease with our AI-powered Application Builder
- Get instant access to country-specific templates
- Prepare and publish global applications 10x faster
- Autofill subsequent applications using AI technology
Tracking & Reporting
Monitor the entire lifecycle of your product from a single user-friendly dashboard
- Track the status of registrations globally
- Receive renewal notifications
- Generate reports on KPIs within seconds
MEDICAL DEVICE CONSULTANTS FOR RA/QA
Get instant access to or international network of 4,000+ regulatory experts
- Receive Verified Answers to Regulatory Questions Fast
- Largest Network of Medical Device Regulatory Consultants
- Collaborate with Multiple Experts for Solutions to Challenging Questions
And the best part? The power of regulatory compliance software is at your fingertips so you can use it when you need it the most. No more waiting for a consultant to return your calls or hitting communication roadblocks with your local distributors. Streamline bringing your medical devices to new markets at your pace.
Why Regulatory Compliance Software is a necessity?
Maintain compliance in 120 countries around the world
Constant monitoring of global regulatory changes
Prepare global applications in 1/10th of the time
Investing in the right regulatory management system is important across industries, but it is especially essential for companies in the life science and medical device field.
A specialized compliance solution for medical devices can help your organization:
- Receive compliance alerts when regulatory changes occur. Always stay up to date on the latest laws and regulations.
- Improve document management by having all your important documentation accessible on one platform. Reduce the risk of lost, incorrect, and duplicate data.
- Ensure effective quality management throughout the product life cycle.
- Establish superior risk management processes to avoid any roadblocks.
- Ease during audits by having all data in one place
Proper compliance can make all the difference when it comes to bringing your medical device to market quickly and maintaining existing devices.And perhaps more importantly, it also helps companies expedite access of medical products to patients around the world. Go above and beyond typical compliance measures with assistance from regulatory compliance software foryour medical devices.
who trust RegDesk
Testimonials
Сountries that we serve
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.
Benefits of Specialized Compliance Software
The medical device industry is complex. You need regulatory compliance software that captures the unique needs of your business. RegDesk software is tailored to the medical device industry. Regulations are constantly evolving and that’s why our solution is continuously being monitored and improved.
With specialized regulatory compliance software, your business is only presented with the relevant information needed to make informed decisions. No more sorting through mountains of irrelevant data or conducting hours of research to move the process along or relying on distributors.
Speed at which you build application
Time to address international inquiries
More applications per year
Eliminate the cost of adding more staff
Cost savings
Our Regulatory Blog
Never miss a thing in the world of medical device regulatory compliance. The latest regulatory news and updates are always on our feed.
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…
