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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.
Description
Leverage Waymark's state-of-the-art technology to equip yourself with the regulatory insights, oversight, and collaborative tools essential for compliance with regulatory requirements. By reducing manual tasks and enhancing workflow, the platform enables seamless collaboration across all defense lines, ultimately saving numerous hours each week and accumulating hundreds of hours annually, thus allowing teams to focus on more impactful projects. With automatic detection of pertinent news and changes in obligations, critical developments are never missed, and all tasks are monitored until completion. Additionally, change management audit trails and comprehensive reports furnish management and board members with the necessary evidence, insights, and assurance to fulfill their responsibilities effectively. Waymark’s AI capabilities excel in identifying, categorizing, and organizing an unparalleled array of sources, including regulatory updates, legal insights, enforcement actions, and other significant news. This comprehensive approach ensures that organizations remain ahead of the curve in compliance and can respond swiftly to evolving regulatory landscapes.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
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
DDi
Founded
1997
Country
United States
Website
www.ddismart.com
Vendor Details
Company Name
Waymark
Country
United Kingdom
Website
www.waymark.tech/