Regulatory
Information
Management (RIM)
for Medical Devices
A modular Regulatory and Process platform for Medical Device / IVD manufacturers to streamline product registration, streamline content processes, manage regulatory impact assessments, automate publishing activities, manage global submissions, and ensure regulatory compliance efficiently.
Global Visibility
Gain a single source of truth for all product registrations and market authorizations worldwide. Track status
in real-time.
Submission Planning
Efficiently plan and track regulatory activities. Manage submission content plans and timelines to ensure country specific compliance is met.
Compliance Tracking
With built in regulatory requirements for over 140 markets, ensure market compliance at all times and see gaps quickly.
UDI, IMDRF, EU MDR and Others
Built-in support for data standards including UDI, ensuring your data is traceable for future compliance.
Seamless Integration
Leverage built in Document Management module or connect to external EDMS, PLM, ERP, QMS and other systems for a connected ecosystem to exchange Data or Documents.
Advanced Analytics
Dashboard analytics provide insights into submission volume, approval times, and workload distribution across regions.
Related Tools & Solutions
Regulatory Impact Assessment (RIA)
Submission & Publishing
Product/License Tracking
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