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
Orthogonal specializes in offering development services that concentrate on the creation and expansion of Software as a Medical Device (SaMD) and interconnected medical device systems, blending cutting-edge engineering techniques with rigorous adherence to regulatory standards. Their methodology encompasses the entire product lifecycle, which includes elements such as user experience design, integration of human factors, requirement specification, risk assessment, Agile software development, and thorough verification and validation processes to guarantee both operational effectiveness and safety. By utilizing Agile methodologies tailored for regulated settings, they facilitate iterative development, promote quicker feedback loops, and encourage ongoing enhancements while ensuring compliance with regulatory frameworks like the FDA, EU MDR, and ISO standards. Moreover, Orthogonal aids in the development of various applications, including mobile, web, and desktop solutions, along with cloud-based systems, artificial intelligence algorithms, and SDKs that facilitate integration with external platforms, empowering medical devices to connect seamlessly, analyze data, and provide valuable insights. This comprehensive approach allows for innovative solutions that not only meet industry standards but also enhance patient care and operational efficiency.
API Access
Has API
API Access
Has API
Integrations
AgentMail
Amazon
Andi
Claude Code
ContactOut
Crustdata
Didit
Fundable
Google Calendar
Linkup
Integrations
AgentMail
Amazon
Andi
Claude Code
ContactOut
Crustdata
Didit
Fundable
Google Calendar
Linkup
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
BrightInsight
Founded
2017
Country
United States
Website
brightinsight.com
Vendor Details
Company Name
Orthogonal
Founded
2025
Country
United States
Website
www.orthogonal.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
Healthcare CRM
Audience Targeting
Campaign Management
Marketing Automation
Medical History Records
Patient Communications
Patient Management
Physician Management
Predictive Analytics
IoT
Application Development
Big Data Analytics
Configuration Management
Connectivity Management
Data Collection
Data Management
Device Management
Performance Management
Prototyping
Visualization