The Regulatory Platform Built to Grow With You
Start where you are. Expand as your regulatory program matures.
Rimsys is structured around the workflows MedTech regulatory teams run every day. Pick the tier that fits your program now and expand as your portfolio and markets grow.
Find Your Fit
Four packages, one shared data foundation.
Start where you are and expand as you grow.
Core
Tier 1
Ideal For
Teams moving off disparate or paper-based processes for the first time.
What's Included
Registrations
Core Submissions
Plus
Tier 2
Ideal For
Teams centralizing product data while accelerating submission workflows; includes core AI.
What's Included
Registrations
Advanced Submissions
Pro
Tier 3
Ideal For
Teams migrating off a legacy or pharma-built platform; unlocks advanced AI-powered regulatory intelligence.
What's Included
Registrations
Advanced Submissions
Intelligence
Optimized
Tier 4
Ideal For
Tech-forward enterprises ready to leverage the full Rimsys platform with advanced AI and live data sync.
What's Included
Registrations
Advanced Submissions
Intelligence
Connect
Add-On Capabilities - Available at Any Tier:
Impact Assessments
Standards & EPs
Universal UDI
Intelligence
Connect
Add-On Capabilities
Layer specific capabilities onto any tier. Each add-on connects directly to your shared product data foundation.
Impact Assessments
Configurable survey templates to manage change impact across your product portfolio.
Standards & EPs
Essential Principles, GSPR traceability, 1.7M standards library, automated change notifications, multi-market compliance.
Universal UDI
Data capture and transmission to FDA GUDID, EU MDR/IVDR. Data capture for SFDA, NMPA, MFDS, and HSA.
Intelligence
Global Regulatory Source Monitoring across 90+ countries for Guidance, Safety Alerts, Product Recalls, News, Legislation/ Regulations, and Events. Covers Medical Device, SaMD, IVD.
Connect
Streams Rimsys regulatory data to your data lake in near real-time for custom reporting and cross-system analysis in your BI tool of choice. Includes Streaming Data for External Systems, Near Real-Time BI Sync, Continuous Data Synchronization, Change Data Capture.
How Pricing Works
Pricing is scoped to your tier and add-ons. No per-user fees. No tier gates.
Contact our team for a quote tailored to your organization.
FAQs
Core is for teams getting off spreadsheets for the first time. Plus adds Advanced Submissions for teams accelerating submission workflows. Pro adds Intelligence for teams migrating off legacy platforms. Optimized adds Connect for tech-forward enterprises leveraging the full platform with live data sync.
Add-ons — Impact Assessments, Standards & EPs, Universal UDI, Intelligence, and Connect — are available at any tier and layer- specific workflows onto your shared data foundation.
Yes. Rimsys is built to grow with you. Start where you are and expand as your regulatory program matures.
Pricing is scoped to your tier and add-ons. No per-user pricing. Contact our team for a quote.
The platform foundation: Permissions & Settings, Products & Dashboards, Tasks & Approvals, Reports & Documents, HA Correspondence, Certificates, Projects & NPI, and Accounts — included at every tier.
Coming Late 2026. Includes AI-Drafted Submissions available for editing. Details to be announced closer to release.
Data capture and transmission for FDA GUDID and EU MDR/IVDR. Data capture for Saudi Arabia SFDA, China NMPA, South Korea MFDS, and Singapore HSA.
Ready to See What Fits Your Program?
The right foundation changes everything.