Regulatory management software purpose-built for medtech teams
Remove information silos, strengthen compliance, and execute plans faster
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The Rimsys Platform
The Rimsys Regulatory Information Management Platform digitizes and automates regulatory activities in a single cloud-based platform, helping regulatory affairs teams work more efficiently, bring products to market more quickly, and reduce non-compliance risks.
Centralize all regulatory information
Create, organize, and consolidate a “single source of truth” for registrations, certificates, submission documents, technical files, UDI, and correspondence with health authorities. Ensure that everyone is working with consistent, up-to-date information.
Manage your regulatory workflows
Track and manage registration and selling status. Digitally author and maintain essential principles tables. Route completed registrations, submissions, and essential principles tables for easy collaboration and approvals.
Automate your regulatory processes
Receive automated alerts and notifications about your products, control selling status, easily assess the impact of product changes, and bulk update essential principles tables when relevant standards change.
All of your RA processes in one integrated platform
Monitor and manage global product registrations, certificates, and expirations
Create and maintain essential principles/general safetey and performance requirements (GSPR) tables
Rimsys integrates across your existing systems
Easily connect clinical, product, and quality information across your organization. Update market clearance and selling status directly in your ERP or CRM for immediate MDSAP compliance.
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