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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

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 

Screenshots View All

Screenshots View All

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 

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