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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 Ennov RIM?

Imagine having all your regulatory information concerning products, registrations, submissions, correspondence, and obligations gathered in one easily navigable space. Ennov RIM empowers life sciences companies to streamline their regulatory processes, improve data accuracy, respond rapidly to critical business questions, and satisfy requests from health authorities efficiently. Tailored for managing and overseeing therapeutic product details and registration information, Ennov RIM is built on the foundation of Ennov Process. Whether you are gearing up to launch a new product or making modifications to existing registrations, Ennov RIM provides regulatory teams with the vital information and tools necessary to effectively manage product portfolios globally. This all-encompassing strategy not only ensures compliance but also facilitates informed decision-making throughout the organization, ultimately driving greater operational success. With Ennov RIM, life sciences companies can thrive in a complex regulatory landscape while maintaining agility and responsiveness.

Media

Media

Integrations Supported

Ennov Regulatory Suite

Integrations Supported

Ennov Regulatory Suite

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

Ennov

Date Founded

1999

Company Location

France

Company Website

en.ennov.com/regulatory-content-information-management/rim-regulatory-information-management/

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