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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 Essenvia?

Essenvia significantly boosts corporate value and enhances operational productivity across multiple teams and departments. Functioning as a centralized repository for all regulatory information, it streamlines collaborative document generation and reporting, while also mitigating risks related to technical holds, RTAs, and RFIs. This innovative platform equips regulatory affairs teams with the tools necessary to expedite product launches, thereby preventing potential revenue losses stemming from delays in submissions and overlooked renewals. Offering a detailed perspective of the complete regulatory lifecycle, Essenvia features executive dashboards, key performance indicators, and timely alerts for global registrations, submissions, and modifications. Acting as a Regulatory Information Management (RIM) platform, it optimizes regulatory workflows throughout the product lifecycle, enabling quicker access to global markets and providing substantial competitive advantages. By unifying all regulatory processes into a single platform, businesses can significantly accelerate their entry into the market. Moreover, it contains a centralized archive for all registration documents, which are seamlessly tied to product master data, empowering users to efficiently oversee the product registration lifecycle on a country-specific basis while ensuring compliance and operational excellence. This holistic approach not only enhances efficiency but also fosters better collaboration among teams.

Media

Media

Integrations Supported

Arena PLM
EQMS
Oracle Fusion Cloud PLM
Qualio

Integrations Supported

Arena PLM
EQMS
Oracle Fusion Cloud PLM
Qualio

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

Essenvia

Company Location

United States

Company Website

essenvia.com

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