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What is ViSU?

ViSUâ„¢ is a cutting-edge cloud platform designed for comprehensive End-to-End Regulatory Information Management (RIM) specifically for the medical device industry, enabling users around the globe to easily access and manage crucial Regulatory Data, such as Product Master information, Registrations, and Tracking. This all-encompassing tool also supports the organization of Dossiers and Technical Files through effective submission planning, development, and lifecycle oversight, while enhancing communication with Health Authorities and Notified Bodies, monitoring obligations, managing Unique Device Identification (UDI), and overseeing electronic Instructions for Use (eIFU), in addition to maintaining a Regulatory Requirements Database and controlling modifications. By implementing ViSU, companies can fully leverage the advantages of digital transformation in their regulatory practices, leading to improved connectivity, greater traceability, and extensive automation. Ultimately, ViSU plays a vital role in boosting regulatory management efficiency, mitigating compliance risks, and decreasing operational expenses, establishing itself as a crucial resource for the sector. Furthermore, the platform's intuitive interface ensures that teams can effortlessly navigate the intricate landscape of regulatory requirements, thereby enhancing overall productivity. This ease of use combined with powerful functionalities positions ViSU as a game-changer in the regulatory management arena.

What is RequirementONE?

RequirementONE is a sophisticated data platform that offers immediate access to worldwide regulatory updates while also providing a collaborative environment for streamlining your processes and tasks. Maximize your efficiency: By becoming a part of RequirementONE, you unlock a robust platform filled with essential tools designed to help you navigate regulatory shifts with confidence. Customize to fit your needs: Stay informed with updates from more than 1,000 regulators, industry bodies, and leading practice sources across relevant jurisdictions. This enables you to take decisive action on a unified platform that meets all your informational and collaborative needs. Analyze and prioritize changes with ease: RequirementONE is the ideal choice for those seeking fully translated regulatory updates from various regions. Our platform ensures that these updates are automatically directed to you, made actionable, and accompanied by a comprehensive change history along with extensive reporting features. We streamline the entire process, enabling you to reduce costs and effort by as much as 80% in a short period. In today’s fast-paced regulatory landscape, RequirementONE is your partner in achieving compliance and efficiency seamlessly. requirementone.com

Media

Media

Integrations Supported

Integrations Supported

Microsoft Power Automate
Zapier

API Availability

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

$12/user, $40/source / month
Pricing tiers:
Try - Daily regulatory email updates
Expand - Track any regulator or topic
Collaborate - Teamwork and integration
Enterprise - Automation and analytics
Free Version
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Windows

Customer Service / Support

Standard Support
24 Hour Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

DDi

Date Founded

1997

Company Location

United States

Company Website

www.ddismart.com

Company Facts

Organization Name

RequirementONE

Date Founded

2020

Company Location

United Kingdom

Company Website

www.requirementone.com

Categories and Features

Categories and Features

Compliance

Compliance Tracking
Risk Management
Workflow / Process Automation

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