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Average Ratings 0 Ratings

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ease 0 out of 5 stars
features 0 out of 5 stars
design 0 out of 5 stars
support 0 out of 5 stars

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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

Vistaar is an innovative platform that operates in the cloud, catering specifically to the regulatory intelligence and compliance needs of organizations in the pharmaceutical, biotechnology, medical device, diagnostics, and consumer health sectors. It boasts a comprehensive and searchable repository of regulatory documents and requirements, while also keeping an eye on developments across more than 150 countries, providing timely alerts and detailed summaries regarding any changes. Users have the ability to examine regulations, guidance, and standards, evaluate their implications on products and operations, delegate tasks, and monitor obligations, deadlines, and evidence through structured workflows and compliance matrices. Enhanced by AI capabilities, the platform offers advanced search functionalities, document summaries, translation services, and obligation extraction to facilitate the regulatory review process efficiently. Curated human-reviewed summaries ensure that users have access to the most relevant requirements for their needs. Additionally, Vistaar includes features for reporting, maintaining audit trails, and integrating seamlessly with existing electronic document management systems, regulatory information management tools, and quality management systems. This platform is designed to support regulatory affairs, quality assurance, and compliance teams as they navigate the intricate landscape of global life sciences regulations, making it an essential tool in their arsenal. By streamlining compliance efforts, Vistaar ultimately empowers organizations to focus on innovation and improving patient outcomes.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

No images available

Integrations

ViSU No 

Integrations

ViSU Yes 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

Free Quick Access provides limited navigation and data-availability checks for one or two countries. The free proof-of-concept pilot provides 7 days of unlimited cloud use with full data for selected countries.
Free Trial Yes 
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) Yes 
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 No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Emergo by UL

Country

United States

Website

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

Vendor Details

Company Name

DDismart

Founded

2015

Country

United States

Website

www.vistaar.ai/

Product Features

Product Features

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