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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 UL SmartInsights?

The SmartInsightsâ„¢ Global Market Access Platform is an online subscription tool that offers quick and easy access to the latest, most reliable, and comprehensive regulatory requirements essential for entering global markets. Designed with a user-friendly interface, this platform helps streamline your path toward achieving compliance on an international scale. With instant access to vital regulatory information, you can adeptly navigate the intricacies of multistage product development and make informed strategic decisions about expanding into new geographic regions or launching additional product lines. Furthermore, you will receive real-time updates on the ever-changing regulatory landscape, ensuring that you remain informed about any new or updated regulations relevant to your specific product category. The database is consistently updated to provide you with timely and applicable requirements, while access can be customized according to the countries and product categories you need, ensuring efficient management of your regulatory obligations. This platform stands out as an essential tool for successfully maneuvering through the challenges of global market access, empowering your organization to thrive in a competitive environment. Additionally, it equips users with the insights necessary to stay ahead of regulatory trends and adapt strategies accordingly.

Media

Media

Integrations Supported

UL PATH SmartSuite

Integrations Supported

UL PATH SmartSuite

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
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

UL

Date Founded

1894

Company Location

United States

Company Website

www.ul.com/services/uls-smartinsights-global-market-access-platform

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