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What is Rimsys?

Rimsys offers a comprehensive cloud-based platform specifically designed for the complete digitization and automation of regulatory processes. Tailored by regulatory affairs experts for their peers, Rimsys enables medtech companies to minimize repetitive tasks, accelerate their market entry, swiftly adapt to evolving regulations, and enhance collaboration among internal teams, partners, and affiliates. What sets Rimsys apart is its all-encompassing platform that facilitates a wide array of regulatory activities. Users can leverage regulatory intelligence along with digital templates to refine their regulatory strategies and simplify submission processes. The platform allows for the creation of compliant, submission-ready documentation and the consolidation of PDF packages for both electronic and print submissions. Moreover, it enables users to digitally gather and uphold evidence of compliance while linking to pertinent standards and receiving alerts about any changes. Rimsys ensures that users stay informed about modifications in standards, laws, regulations, and guidance documents affecting their products. Additionally, the platform offers the ability to generate self-service reports on applications, products, and countries, allowing users to track where their products can be marketed and their current registration statuses, thus further enhancing regulatory efficiency.

What is RAMS?

The Regulatory Affairs Management Suite (RAMS) by Emergo, a UL company, provides a comprehensive software-as-a-service platform designed to streamline regulatory and quality management for businesses in the medical device and in vitro diagnostics sectors. Leveraging deep regulatory compliance knowledge, RAMS offers an array of tools that enable users to adeptly maneuver through the complex and evolving landscape of global medical device regulations. A notable feature includes product classification, which helps users by leading them through a systematic series of questions to determine or verify their device classifications accurately. The Smart Builder feature provides detailed, step-by-step guidance along with pre-written text to assist in the development of precise regulatory documents, making the process of device registration more efficient and accelerating market access. Additionally, the Registration Tracker automates the management of international certifications and registrations, helping organizations to stay on top of renewals and maintain compliance consistently. By adopting this proactive methodology, companies not only improve their operational efficiency but also effectively mitigate the likelihood of regulatory challenges, allowing them to focus on innovation and growth in the competitive medical device market. Ultimately, RAMS empowers businesses to navigate regulatory landscapes with confidence and agility.

Media

Media

Integrations Supported

Arena PLM
Arena QMS
Cortellis
ETQ Reliance
Microsoft Dynamics 365
PTC Windchill
SAP ERP

Integrations Supported

Arena PLM
Arena QMS
Cortellis
ETQ Reliance
Microsoft Dynamics 365
PTC Windchill
SAP ERP

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Rimsys Regulatory Management Software

Date Founded

2017

Company Location

United States

Company Website

www.rimsys.io/products/rimsys-platform

Company Facts

Organization Name

Emergo by UL

Company Location

United States

Company Website

www.emergobyul.com/software/regulatory-affairs-management-suite

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