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Description
Establish a structured approach to cyber, compliance, and risk notification responsibilities to ensure uniform, documented, and cooperative event management. Radar Compliance serves as a customizable rules and assessment platform that allows you to set your own notification triggers and obligations, accommodating internal teams, regulatory bodies, and third-party requirements. This leads to an organization-wide approach to event management that is consistent, well-documented, and collaborative. By removing subjectivity from incident evaluations, the need for spontaneous notifications is eliminated. This process also provides transparency and is audit-friendly for both internal and external parties. In addition, it fosters efficient incident management across various departments. The system features a fully automated assessment mechanism that evaluates all pertinent risk factors and incident data related to a particular event while programmatically determining the "material risk" based on the rules that are most significant to your organization. Furthermore, this comprehensive solution promotes a culture of accountability and proactive risk management within the organization.
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
Protenus
Radar Privacy
ServiceNow
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
RadarFirst
Founded
2016
Country
United States
Website
www.radarfirst.com/product/radar-compliance/
Vendor Details
Company Name
DDi
Founded
1997
Country
United States
Website
www.ddismart.com