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
Regardless of the industry, businesses, governmental entities, and communities globally are facing a dynamic regulatory environment, which includes issues such as international data privacy and the need to harmonize economic advancement with the transition to a low-carbon economy. This evolving landscape brings about shifts in regulations and intensifies both government oversight and public scrutiny regarding how businesses operate and adhere to compliance standards. Totum focuses on providing cloud-based compliance management solutions. Initially designed for the heavily regulated oil and gas sector, Totum Compliance offers a comprehensive and automated method for addressing compliance needs at both local and global levels, ensuring that operational teams receive pertinent and timely information. By establishing a unified source of truth, we empower organizations to effectively navigate the intricate and extensive array of obligations required to uphold their legal and social licenses to operate, regardless of their location on the globe. This ultimately enhances their capacity to adapt to regulatory changes and meet stakeholder expectations efficiently.
API Access
Has API
No
API Access
Has API
No
Integrations
Microsoft Azure
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
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
No
Webinars
No
Live Training (Online)
Yes
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
Totum Compliance
Founded
2013
Country
New Zealand
Website
totumcompliance.com
Product Features
Product Features
Oil and Gas
Compliance Management
No
Equipment Management
No
Inventory Management
No
Job Costing
No
Logistics Management
No
Maintenance Management
No
Material Management
No
Project Management
No
Resource Management
No
Scheduling
No
Work Order Management
No