Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
RequirementONE is an advanced data platform that provides instant access to global regulatory advancements and serves as a collaborative space for digitalizing your processes and tasks.
Enhance your productivity:
By joining RequirementONE, you gain entry to a comprehensive platform equipped with all the tools necessary to confidently address regulatory changes.
Tailor to your needs:
Access regulatory updates from over 1000 regulators, industry organizations, and best practice sources in relevant jurisdictions. Take action on a single platform that covers all your informational and collaborative requirements.
Efficiently analyze and prioritize changes:
RequirementONE is the ultimate solution if you require fully translated regulatory updates across multiple regions. Our platform automatically routes them to you, ensures their actionability, and maintains a complete change history with extensive reporting capabilities.
We simplify the process, allowing you to save up to 80% in costs and effort in no time.
requirementone.com
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
Microsoft Power Automate
Zapier
Pricing Details
$12/user, $40/source / month
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
RequirementONE
Founded
2020
Country
United Kingdom
Website
www.requirementone.com
Vendor Details
Company Name
DDi
Founded
1997
Country
United States
Website
www.ddismart.com
Product Features
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation