RAMS

RAMS

Emergo by UL
+
+

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About

BrightInsight accelerates time to market for our customers’ digital health products, including apps, algorithms, medical devices, connected combination products, diagnostics, and Software as a Medical Device (SaMD) across therapeutic areas. BrightInsight replaces the need for lengthy and complicated ‘build from scratch’ implementations and instead offers a pre-built and proven digital health platform designed under a Quality Management System to support global security, privacy, and regulatory requirements. We helped Roche launch a Software as a Medical Device (SaMD) dosing calculator for hemophilia A in 6 months in Europe, and accelerated a Top 10 Biopharma companies remote patient platform from project kickoff to commercialization in less than a year. We are experts at building and maintaining biopharma and medtech regulated digital health products, with multiple commercial launches in the last year alone.

About

Emergo by UL's Regulatory Affairs Management Suite (RAMS) is a comprehensive software-as-a-service platform designed to streamline regulatory and quality management for medical device and in vitro diagnostic companies. Leveraging decades of regulatory compliance expertise, RAMS offers a suite of tools to navigate the complex and evolving landscape of global medical device regulations. Key features include product classification, which guides users through a series of questions to determine or verify device classification, and Smart Builder, a tool that provides step-by-step guidance and templated text to create accurate regulatory documentation, facilitating smoother device registration and faster market access. The Registration Tracker automates the tracking of global registrations and certifications, helping organizations avoid missed renewals and maintain compliance.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Global IoT platform for biopharma and medtech companies

Audience

Regulatory affairs professionals looking for a solution to streamline compliance processes and maintain up-to-date knowledge of global regulatory requirements

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

BrightInsight
Founded: 2017
United States
brightinsight.com

Company Information

Emergo by UL
United States
www.emergobyul.com/software/regulatory-affairs-management-suite

Alternatives

Alternatives

AlphaMED

AlphaMED

Alpha Software
MedAffairs AI

MedAffairs AI

Accreditation Council for Medical Affairs (ACMA)
LICENSALE

LICENSALE

Arazy Group

Categories

Categories

Compliance Features

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

Healthcare CRM Features

Audience Targeting
Campaign Management
Marketing Automation
Medical History Records
Patient Communications
Patient Management
Physician Management
Predictive Analytics

IoT Features

Application Development
Big Data Analytics
Configuration Management
Connectivity Management
Data Collection
Data Management
Device Management
Performance Management
Prototyping
Visualization

Integrations

No info available.

Integrations

No info available.
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