Built under a Quality Management System to support regulated products, our medical-grade BrightInsight™ Platform uses software and services to capture, transmit and analyze data from connected medical devices, combination products, apps, Digital Therapeutics and Software as a Medical Device- all in compliance with security, privacy and regulatory requirements.
We handle global regulatory compliance, so you don’t have to.
- BrightInsight supports CE-Marked and FDA-regulated class I, II and III medical devices, combination products and Software as a Medical Device (SaMD)
- Our cutting-edge Quality Management System is ISO 13485:2016 certified
- We provide compliant change control for the continuously evolving cloud infrastructure
- BrightInsight’s Device Master File has been accepted by the FDA and can simply be referenced in your regulatory submission
Our open architecture is flexible and future-proof.
- A device-agnostic solution, BrightInsight can easily support multiple products
- The microservices architecture provides advanced security, scalability and customization options
- Built with clinical workflow integration in mind, BrightInsight integrates with Electronic Medical Records (EMRs) and other Health IT systems
Our managed service model means less cost, less stress and accelerated time to market.
- By removing the need to build and manage a custom platform, BrightInsight helps you get to market faster
- Our managed service model dramatically reduces upfront expenditures and maintenance costs
- A single platform replaces a mishmash of tools, simplifying the underlying infrastructure and vendor management for our customers
- Built from the ground up to serve customers with multiple products, our platform scales to suit your needs
Real-time intelligence to optimize your therapies.
- BrightInsight generates real-time insights from real-world drug and device data
- Our Engagement Dashboard provides analytics to enable proactive patient communication and data-driven app optimization
- Our Adherence Dashboard provides drug and device utilization data to support real-world evidence of drug adherence
- Our Operations Dashboard provides insights to track commercial KPIs for product launches, revenue trending, patient demographic information and more