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Description
Documents categorized by agency activities can be found all in one location. You can easily review details such as violations, respondents, and penalty amounts organized by agency on a weekly basis. Additionally, stay informed with trending news and important deadlines like comment closures, effective dates, and notice periods. While traditional Governance, Risk, and Compliance (GRC) software has been around for a while, these tools were not built to tackle the specific issues linked to Regulatory Change Management (RCM). In fact, at the time those software solutions were created, the necessary technology to facilitate RCM operations was not yet available. Moreover, existing GRC software lacks the capability to proactively track new regulatory information sources, automatically analyze and enhance new regulatory content, or empower compliance, risk, and legal teams to establish an RCM command center for monitoring their compliance status effectively. This limitation highlights the need for more advanced tools tailored to the ever-evolving landscape of regulatory requirements.
Description
ViSU™ is an innovative cloud-based platform for End-to-End Regulatory Information Management (RIM) tailored for the medical device sector, allowing users worldwide to efficiently access and oversee essential Regulatory Data, including Product Master details, Registrations, and Tracking. This comprehensive tool also facilitates the management of Dossiers and Technical Files through submission planning, development, and lifecycle management, while streamlining communication with Health Authorities and Notified Bodies, tracking obligations, managing Unique Device Identification (UDI), electronic Instructions for Use (eIFU), maintaining a Regulatory Requirements Database, and controlling changes. By adopting ViSU, organizations can fully harness the power of digital transformation in regulatory processes, achieving improved connectivity, enhanced traceability, and significant automation. Ultimately, ViSU contributes to heightened regulatory management efficiency, reduced compliance risks, and lowered operational costs, making it an indispensable asset for the industry. Moreover, its user-friendly interface ensures that teams can navigate the complexities of regulatory requirements with ease.
API Access
Has API
API Access
Has API
Integrations
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Integrations
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Pricing Details
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Free Trial
Free Version
Pricing Details
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Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Compliance.AI
Founded
2016
Country
United States
Website
www.compliance.ai/
Vendor Details
Company Name
DDi
Founded
1997
Country
United States
Website
www.ddismart.com
