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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

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 No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) Yes 
In Person No 

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/

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