Bringing regulatory order to medtech

Streamline global regulatory processes, strengthen compliance, and get to market faster with the leading regulatory information management software for medtech.

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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
Hologic
Novartis
Cooper Companies
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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 reduce manual administrative work and confidently manage global compliance.

Centralize Regulatory Information

Centralize all regulatory information

Create, organize, and consolidate a “single source of truth” for all documents and information. Ensure that everyone is working with consistent, up-to-date information.

Streamline submissions

Automate product registrations with country-specific entrance requirements, pre-built templates, approval workflows, digital authoring, and PDF publishing.

Device & Product Description
Registrations MapMonitor Market Status

Monitor market status

Automatically track expirations, relevant standards, and changing regulations, to ensure products can stay on the market without disruption.

All of your RA processes in one integrated platform

Product registration

Create, monitor, and manage global registrations and regulatory applications

Unique device identification

Manage global UDI information alongside product registrations

Regulatory intelligence

Track relevant laws, regulations, guidance, and news

Essential principles

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

Standards management

Proactively monitor changing global standards

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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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