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ease
features
design
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

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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

$2,361
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

Visual Enterprise Solutions

Founded

1998

Country

Denmark

Website

www.visual-quality.com

Product Features

Product Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Alternatives

Alternatives

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Accreditation Council for Medical Affairs (ACMA)