Turn regulatory into revenue with medtech-focused RIM software

Plan better, execute faster, and ensure global regulatory compliance

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Essential PrinciplesManage Registrations
The trusted technology partner for medtech regulatory affairs
Customer stories
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Johnson & Johnson
Smith + Nephew
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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.

Streamline submissions

Collaborate with team members and in-country sponsors to quickly assemble regulatory applications using pre-built digital templates, intelligent reusable content, and automated approval workflows.

Device & Product Description
Registrations MapMonitor Market Status

Monitor market status

Automatically track registration and selling status, expirations, relevant standards, and regulatory news to ensure products can stay on the market without disruption.

All of your RA processes in one integrated platform

Product registrations

Monitor and manage global product registrations, certificates, and expirations


Collaboratively author and assemble 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

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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