Regulatory management software purpose-built for medtech teams

Remove information silos, strengthen compliance, and execute plans faster

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Essential PrinciplesManage Registrations
The trusted technology partner for medtech regulatory affairs
Customer stories
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Omron
Siemens
Johnson & Johnson
Smith + Nephew
Terumo
Novartis
Avanos
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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 Regulatory Information

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.

Device & Product Description
Registrations MapMonitor Market Status

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

Product registrations

Monitor and manage global product registrations, certificates, and expirations

Submissions

Collaboratively author and assemble regulatory applications

Unique device identification

Manage global UDI information alongside product registrations

Essential principles

Create and maintain essential principles/general safetey and performance requirements (GSPR) tables

Standards management

Proactively monitor and manage changing global standards

Regulatory intelligence

View market entrance requirements for over a dozen markets

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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