RegDesk Regulatory Compliance
Software For Medical Devices
Regulatory Compliance Simplified
The only RIM platform, with built-in regulatory intelligence and AI-powered automation that allows management of change assessment and preparation of international submissions within hours compared to months.
![Dashboard to track international registrations | RegDesk](https://www.regdesk.co/wp-content/uploads/2023/04/Hero-illustration-1-1-1.png)
Dashboard to track global registrations
What is RegDesk?
Complying with differing global regulations creates exponential complexity – and the pace of change continues to accelerate. To keep pace, investing in a holistic regulatory platform has become critical. RegDesk can help.
TRUSTED BY LEADING COMPANIES
BENEFITS OF REGDESK'S RIM PLATFORM
Prepare international applications within 1 week instead of 4 months
Reduce response time to address international inquiries from 6-8 weeks to less than 20 hours
Avoid stress and nonconformities from a Health Agency audit
Why RegDesk RIMS
With RegDesk, expand to 120+ global markets ahead of your competitors. We make compliance with global and local laws and regulations easy for specialized pharma and medical device companies.
![](https://www.regdesk.co/wp-content/uploads/2023/04/Bird-1.png)
This is what makes us unique
Regulatory Intelligence
Develop fast and reliable regulatory strategy and manage potential vulnerabilities proactively through our comprehensive regulatory intelligence.
- Access up-to-date regulatory requirements for 120 markets
- Receive daily alerts on changing regulations
- Obtain timelines and costs per country
![Person On A Chair Looking At The World Map | RegDesk](https://www.regdesk.co/wp-content/uploads/2023/04/Group-105-1.png)
AI Submission Generator
Reduce your time to prepare, publish, and submit global applications from months to only a week using RegDesk’s AI technology.
- Access country-specific, submission ready templates
- Prepare and publish global applications in formats acceptable by regional health agencies
- Leverage AI to autopopulate applications for subsequent countries
![Person Working On A Laptop With AI | RegDesk](https://www.regdesk.co/wp-content/uploads/2023/04/Group-113-1.png)
Tracking & Reporting
Monitor the entire lifecycle of your product and never again miss a renewal or ship a wrong product to a country.
- Track the status of registrations by product name and SKU
- Receive renewal notifications
- Generate reports on key performance indicators within seconds
![Person Tracking Regulatory Submissions Progress | RegDesk](https://www.regdesk.co/wp-content/uploads/2023/04/TRACKING-Illustration-2-1.png)
Standards Management
Maintain compliance of standards and guidances worldwide and avoid non-conformities from audits.
- Search for international and country-specific standards and guidance documents
- Manage gap assessments on standards through integrated workflows
- Receive notifications on changing standards and guidance documents that affect your products
![People Receiving Alerts On Changing Medical Device Compliance Standards | RegDesk](https://www.regdesk.co/wp-content/uploads/2023/04/Group-106-2.png)
Change Assessment
Manage global impact of changes to a product faster and with ease through the Only Change Assessment Tool available with built-in regulatory intelligence.
- Understand the regulatory impact of changes to an existing product
- Generate report to see which products, countries, and SKUs will be impacted
- Manage change control workflows to collaborate with internal and external teams
![Three People Discussing Medical Device Product Changes | RegDesk](https://www.regdesk.co/wp-content/uploads/2023/04/Group-68-1.png)
AI Form Builder (GSPR, DoC, Requirements)
Decrease staff hours and errors by auto-generating GSPR, Declaration of Conformity (DoC), and Essential Requirements documents using RegDesk’s AI capability.
- Utilize AI and machine learning to auto-populate GSPR, DoC, and Essential Requirements
- Track which submission documents require change when a standard changes
- Automate bulk updates of the GSPR, DoC, and Essential requirements
![Person Looking At A Screen With](https://www.regdesk.co/wp-content/uploads/2023/04/Group-112-1.png)
Testimonials
Industries We Serve
Medical Device
Holistic RIM Solution with built-in Regulatory Intelligence for:
- Medical Devices
- In Vitro Diagnostics
- Software as a Medical Device
- Radiation Emitting
![Pharmaceuticals Graphic | RegDesk](https://www.regdesk.co/wp-content/uploads/2023/04/Pharma-1.png)
Pharmaceutical
Comprehensive Regulatory Intelligence for:
- Pharmaceuticals
- Biologics
- APIs
- Excipients
Сountries we serve
We can help you expand to 120+ markets in the world.
REGDESK REGULATORY ROUNDUP
Never miss a thing in the world of medical device regulatory compliance. The latest regulatory news and updates are always on our feed.