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Description
Cockpit Enterprise, our software application for medium-sized to large medical device product developers, integrates requirements management and test management in a single environment. Cockpit Enterprise can be customized to meet the needs of any company. It offers a rich development environment that allows organizations to implement Standard Operating Procedures (SOPs), and Work Instructions(WIs) in a controlled, auditable environment. Cockpit Enterprise is a tool that helps medical device manufacturers of Class II or III devices to author, review, and approve documents necessary for regulatory submissions. Cockpit Enterprise is best for mature companies that have established standard operating procedures, and can devote the necessary resources to configuring the system and deploying it.
Description
Gain all the necessary resources to effectively register your medical device or IVD product in global markets while overseeing your market access license throughout the product's life cycle. REGISLATE® equips users with comprehensive submission file requirements tailored to specific medical and IVD device needs for each country. With this platform, you can monitor milestones, timelines, as well as estimated and actual completion dates for initial registrations, renewals, amendments, and license transfers as they happen. Additionally, it offers infographic data and exclusive indicators to facilitate transparent oversight and management of every project. Take advantage of collaboration tools that assist in the preparation and review of submissions, ensuring compliance with all necessary requirements and documentation. Stay informed with real-time progress reports on both current and upcoming submissions, including insights into market access readiness. Furthermore, REGISLATE® features GR-MAP registration tracking, providing comprehensive oversight for both the country and product involved. This holistic approach ensures that users are well-equipped to navigate the complexities of market access efficiently.
API Access
Has API
API Access
Has API
Integrations
Act!
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
Cognition
Founded
1995
Country
United States
Website
cognition.us
Vendor Details
Company Name
Arazy Group
Country
Canada
Website
arazygroup.com/regislate-software/
Product Features
Requirements Management
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes