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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

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 

Screenshots View All

Screenshots View All

Integrations

Microsoft Azure No 

Integrations

Microsoft Azure Yes 

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 

Alternatives

Alternatives

SAS for Oil & Gas Reviews

SAS for Oil & Gas

SAS Institute
MedAffairs AI Reviews

MedAffairs AI

Accreditation Council for Medical Affairs (ACMA)