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Average Ratings 0 Ratings
Description
Streamline every stage of the development lifecycle with a flexible solution built for SxMD. Efficiently manage design controls from requirements to compliance with end-to-end traceability to mitigate risk.
Innovate faster with a flexible item-based approach to documentation designed to meet even the most complex SxMD product needs.
Enhance quality management with full traceability from design input to output with a purpose-built software platform that enables a collaborative quality culture across all teams.
Take charge of evolving design, quality, and regulatory requirements while empowering team autonomy and get your product on the front line faster.
Ensure frictionless alignment between platforms with native integrations for Jira, GitLab, GitHub, Azure DevOps and more. Leverage our REST API to connect with all your tools.
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
Azure DevOps
Confluence
GitHub
GitLab
Jira
Matrix Quality
Pricing Details
$500 per 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
Matrix Requirements
Founded
2016
Country
United States, Germany, France, Belgium, United Kingdom
Website
matrixreq.com
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