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Average Ratings 4 Ratings

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features
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support

Description

Emergo by UL's Regulatory Affairs Management Suite (RAMS) is an all-encompassing software-as-a-service solution crafted to optimize regulatory and quality management processes for companies involved in medical devices and in vitro diagnostics. Drawing on extensive expertise in regulatory compliance, RAMS equips users with a range of tools to effectively navigate the intricate and ever-changing realm of global medical device regulations. Among its standout features is product classification, which assists users by guiding them through a structured series of inquiries to ascertain or confirm the classification of their devices. Additionally, the Smart Builder offers comprehensive step-by-step instructions and ready-made text to aid in the creation of precise regulatory documentation, thereby facilitating a smoother path to device registration and expedited market entry. Furthermore, the Registration Tracker serves to automate the oversight of international registrations and certifications, ensuring that organizations do not overlook renewals and consistently uphold compliance standards. This proactive approach not only enhances efficiency but also significantly reduces the risk of regulatory setbacks.

Description

RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies. • Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes • Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time • Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required • Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners • Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards • Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds For more information, visit our website.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Active Directory No 
Arena No 
Asana No 
Boomi No 
Dynamics 365 Customer Service No 
Jira No 
MuleSoft Anypoint Platform No 
Okta No 
OpenText AI Operations Management No 
Oracle ADF Faces No 
PTC Windchill No 
Qualio No 
Resource Management by Smartsheet No 
SnapLogic No 

Integrations

Active Directory Yes 
Arena Yes 
Asana Yes 
Boomi Yes 
Dynamics 365 Customer Service Yes 
Jira Yes 
MuleSoft Anypoint Platform Yes 
Okta Yes 
OpenText AI Operations Management Yes 
Oracle ADF Faces Yes 
PTC Windchill Yes 
Qualio Yes 
Resource Management by Smartsheet Yes 
SnapLogic Yes 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

Contact us to learn more.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) No 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Emergo by UL

Country

United States

Website

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

Vendor Details

Company Name

RegDesk

Founded

2014

Country

United States

Website

www.regdesk.co

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