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Description
RegPass™ serves as a compliance co-pilot designed to amplify your team's effectiveness tenfold. It seamlessly integrates every phase of the regulatory change lifecycle, from horizon scanning to assurance: Horizon Scanning → Rules Inventory → Policies & Controls → Regulatory Policy Advisor.
With extensive global coverage and smart Business Profiles that tailor alerts to what matters most, you can remain proactive. Our enhanced Rules Inventory streamlines overlapping obligations into clear, canonical forms for better traceability and understanding.
At the core of RegPass is AI, which extracts, ranks, and aligns obligations to your existing policies and controls, providing thorough justification for each recommendation. Every recommendation is well-documented, auditable, and primed for your approval.
Developed by the specialists at Braithwate, RegPass encapsulates years of regulatory change knowledge into a dynamic knowledge graph. With its open, extensible, and inherently transparent design, RegPass ensures complete traceability, enabling teams to operate more efficiently, minimize risk, and bolster compliance. By leveraging such a powerful tool, organizations can navigate the complexities of regulatory landscapes with confidence and clarity.
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
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Integrations
Archer
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
RegPass
Founded
2019
Country
United Kingdom
Website
www.regpass.ai
Vendor Details
Company Name
DDi
Founded
1997
Country
United States
Website
www.ddismart.com