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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 Innovatum?

Innovatum offers a comprehensive solution for labeling and regulatory data management specifically designed for organizations in the life sciences field, including those operating in pharmaceuticals, medical devices, and biotechnology. At the heart of their services is the ROBAR platform, which serves as an enterprise-level label management system that oversees all aspects of the label lifecycle, encompassing master-data management (PIMS/MDM), artwork and version control (with built-in support for Adobe files), and regulatory data submissions (such as UDI/MDR/IVDR/Eudamed and GS1 data pool), ultimately leading to the final stages of label printing, print-inspection integration, and compliant archiving. The platform's architecture is highly configurable, enabling users to implement enhancements to the core system without requiring significant reengineering during upgrades, and it can be deployed across various environments, including on-premises, hosted, or single-tenant cloud/SaaS solutions, thus catering to diverse IT infrastructure needs. Moreover, Innovatum includes an eLabeling (eIFU) module that links products, their iterations, and translations to electronic instructions for use, significantly improving user access and regulatory compliance. This all-encompassing system not only optimizes operational processes but also guarantees that users maintain adherence to regulatory standards. In addition, Innovatum's commitment to innovation in label management continues to evolve, ensuring that clients remain at the forefront of compliance and efficiency in their respective industries.

Media

Media

Integrations Supported

Adobe Creative Cloud
HL7 FHIR

Integrations Supported

Adobe Creative Cloud
HL7 FHIR

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

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

Innovatum

Date Founded

1993

Company Location

United States

Company Website

www.innovatum.com

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