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
The division of all document versions or registration folders into distinct modules based on their status (such as draft, approved, valid, and historic) throughout their lifecycle provides a distinctive perspective on the document management system. The process of creating registration forms with the integrated HTML editor, along with registration fields and workflows, is straightforward; additionally, the registration capabilities in Visual Quality are significantly more advanced than those offered by our competitors. Registrations are handled—whether created or approved/rejected—through Visual Quality Web Access. With the support of the vibrant Visual Quality community contributing to the product's development, Visual Quality is rapidly progressing. Our development timeline is notably ambitious, and we are dedicated to providing you with top-tier software to establish and uphold your quality management system. This commitment to innovation ensures that our users always have access to the latest features and improvements in the industry.
API Access
Has API
No
API Access
Has API
No
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Pricing Details
$2,361
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
Yes
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
Yes
Webinars
No
Live Training (Online)
No
In Person
Yes
Vendor Details
Company Name
Emergo by UL
Country
United States
Website
www.emergobyul.com/software/regulatory-affairs-management-suite
Vendor Details
Company Name
Visual Enterprise Solutions
Founded
1998
Country
Denmark
Website
www.visual-quality.com
Product Features
Product Features
Quality Management
Audit Management
No
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
No
Supplier Quality Control
Yes
Training Management
No