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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
Ensuring compliance is crucial for safeguarding a business against policy breaches, which can lead to significant reputational harm and substantial financial penalties. Effective statutory compliance management streamlines the organization of various compliance documents and their renewals, providing timely notifications in a straightforward format. Alerts and reminders regarding compliance will be communicated via SMS and Email to the designated users as well as to escalation contacts and other relevant stakeholders involved in compliance efforts.
The implementation of e-compliance software allows companies to standardize their compliance procedures, thereby mitigating the risk of non-compliance. This solution empowers users to schedule regular compliance tasks within a unified web-based or cloud-enabled platform, simplifying the execution process. By utilizing this digital tool, organizations can efficiently manage a multitude of regulatory obligations while also configuring necessary conditions for successful regulatory compliance management. Additionally, this integrated approach fosters greater accountability among team members, ensuring that compliance remains a top priority across the organization.
API Access
Has API
API Access
Has API
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Integrations
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Free Trial
Free Version
Pricing Details
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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
eCompliance Software
Founded
2002
Country
India
Website
www.ecompliancesoftware.in
Product Features
Product Features
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation