Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
No images available
Integrations
ViSU
No
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
Alternatives
Alternatives
No Alternatives