Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
BrightInsight significantly shortens the time it takes for clients to bring their digital health solutions to market, which encompasses apps, algorithms, medical devices, connected combination products, diagnostics, and Software as a Medical Device (SaMD) across various therapeutic domains. By utilizing a pre-built and validated digital health platform that adheres to a comprehensive Quality Management System, BrightInsight eliminates the need for time-consuming and complex custom implementations while ensuring compliance with global security, privacy, and regulatory standards. For example, we assisted Roche in launching a Software as a Medical Device (SaMD) dosing calculator for hemophilia A in just six months in Europe, and we expedited a remote patient platform for a Top 10 Biopharma company from the initial project kickoff to market readiness in under a year. Our expertise lies in the development and maintenance of regulated digital health products for both the biopharma and medtech sectors, having achieved multiple successful commercial launches within the past year alone. This proficiency enables us to respond swiftly to industry demands while maintaining the highest standards of quality and compliance.
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.
API Access
Has API
No
API Access
Has API
Yes
Integrations
Azure DevOps
No
Confluence
No
GitHub
No
GitLab
No
Jira
No
Matrix Quality
No
Integrations
Azure DevOps
Yes
Confluence
Yes
GitHub
Yes
GitLab
Yes
Jira
Yes
Matrix Quality
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
$500 per month
Free Trial
Yes
Free Version
Yes
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
BrightInsight
Founded
2017
Country
United States
Website
brightinsight.com
Vendor Details
Company Name
Matrix One
Founded
2016
Country
United States, Germany, France, Belgium, United Kingdom
Website
matrixone.health/products/matrix-req
Product Features
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
Yes
ISO Compliance
Yes
Incident Management
No
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
No
Healthcare CRM
Audience Targeting
Yes
Campaign Management
Yes
Marketing Automation
No
Medical History Records
Yes
Patient Communications
Yes
Patient Management
Yes
Physician Management
Yes
Predictive Analytics
Yes
IoT
Application Development
No
Big Data Analytics
Yes
Configuration Management
Yes
Connectivity Management
Yes
Data Collection
No
Data Management
Yes
Device Management
Yes
Performance Management
No
Prototyping
No
Visualization
No
Product Features
Requirements Management
Automated Functional Sizing
No
Automated Requirements QA
No
Automated Test Generation
No
Automated Use Case Modeling
No
Change Management
Yes
Collaboration
Yes
History Tracking
Yes
Prioritization
Yes
Reporting
Yes
Status Reporting
Yes
Status Tracking
Yes
Summary Reports
Yes
Task Management
Yes
To-Do List
No
Traceability
Yes
User Defined Attributes
Yes