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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.

What is Ennov Regulatory Suite?

The Ennov Regulatory Suite stands out as a premier solution for managing regulatory content and information. This comprehensive, centralized platform facilitates the entire regulatory information workflow, spanning from initial stages to market authorization. Companies aiming for excellence in regulatory operations commonly adopt this approach because it fosters harmonization and promotes standardization, enhances collaboration while ensuring compliance, reduces waste and costs, accelerates time-to-market, and enables them to effectively compete in the global arena. The suite includes Ennov Doc, Ennov Dossier, and Ennov Process, which collectively support the complete regulatory product lifecycle, from the early phases of setting registration goals to the eventual retirement of products. By utilizing the Ennov Regulatory Suite, organizations can strategically plan their regulatory activities and streamline their processes efficiently. This makes it an indispensable asset for companies navigating the complexities of regulatory compliance.

Media

Media

Integrations Supported

Ennov RIM

Integrations Supported

Ennov RIM

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

Emergo by UL

Company Location

United States

Company Website

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

Company Facts

Organization Name

Ennov

Date Founded

1999

Company Location

France

Company Website

en.ennov.com

Categories and Features

Categories and Features

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

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Accreditation Council for Medical Affairs (ACMA)