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 Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

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 Not Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Supported

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 Supported
Webinars Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Supported
Live Online Not Supported
In Person Supported

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)
Altis Labs Nota

Altis Labs Nota

Altis Labs
LICENSALE

LICENSALE

Arazy Group

Categories

Compliance Supported
Healthcare CRM Supported
IoT Supported

Categories

Medical Affairs Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Not Supported
Controls Testing Not Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Supported
Incident Management Not Supported
ISO Compliance Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Not Supported

Healthcare CRM Features

Audience Targeting Supported
Campaign Management Supported
Marketing Automation Not Supported
Medical History Records Supported
Patient Communications Supported
Patient Management Supported
Physician Management Supported
Predictive Analytics Supported

IoT Features

Application Development Not Supported
Big Data Analytics Supported
Configuration Management Supported
Connectivity Management Supported
Data Collection Not Supported
Data Management Supported
Device Management Supported
Performance Management Not Supported
Prototyping Not Supported
Visualization Not Supported

Integrations

No info available.

Integrations

No info available.
Claim BrightInsight and update features and information
Claim BrightInsight and update features and information
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Claim RAMS and update features and information