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features
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support

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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

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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Microsoft Azure

Integrations

Microsoft Azure

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

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
Equipment Management
Inventory Management
Job Costing
Logistics Management
Maintenance Management
Material Management
Project Management
Resource Management
Scheduling
Work Order Management

Alternatives

Alternatives

SAS for Oil & Gas Reviews

SAS for Oil & Gas

SAS Institute
MedAffairs AI Reviews

MedAffairs AI

Accreditation Council for Medical Affairs (ACMA)