Our robust platform is built and ready to accelerate your digital health journey.

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 and surgical equipment, combination products, apps, Digital Therapeutics and Software as a Medical Device- all in compliance with security, privacy and regulatory requirements.

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Connectivity

BrightInsight offers connectivity and management for regulated apps, algorithms, surgical equipment and medical devices, combination products or Digital Therapeutics.

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Data Management

BrightInsight can aggregate data from multiple sources and can integrate with EHRs and other IT systems.

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Analytics and Insights

Clinical, operations and patient engagement dashboards provide valuable insights in real-time.

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3 questions to ask regarding your digital health regulatory strategy

Today’s digital health regulatory landscape is a topic of growing concern as more and more biopharma and medtech companies are developing Digital Therapeutics, Software as a Medical Device (SaMD), connected combination products, companion apps and more.

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“Why do I need a regulated Internet of Things (IoT) infrastructure?”

“Why can’t I use a Medical Device Data System (MDDS)?”

“What’s the difference between GxP-compliant and a regulated infrastructure?”

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
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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 Health Records (EHRs) and other Health IT systems
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We actively address ongoing privacy and security requirements around the world.

  • Ongoing operational and administrative security safeguards including response and forensics analysis, regular vulnerability assessment and risk analysis, regular internal and third-party penetration testing, security updates and patching, regular testing for disaster recovery, and regular third-party audits
  • Defense-in-depth architecture with multiple dimensions of technical controls
  • Privacy compliance support, including audit logs, data retention, incident response and breach notifications, Data Protection Impact Assessment, and patient consent management.
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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
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How to Future-Proof your Digital Health Platform

Biopharma and medtech executives are faced with a number of complex considerations when developing a digital health platform.

This white paper offers recommendations for a path forward to launching a scalable, intelligent, digital health platform that meets your company’s needs.

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