Our proven, compliant platform accelerates your digital health journey

BrightInsight replaces the need for lengthy and complicated ‘build from scratch’ implementations and instead offers a pre-built and proven digital health platform designed under a Quality Management System to support global security, privacy, and regulatory requirements.

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Learn how our proven, compliant cloud-based digital health platform accelerates time to market for biopharma and medtech regulated digital health solutions

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Accelerate time to market

We helped Roche launch a Software as a Medical Device (SaMD) dosing calculator for hemophilia A in 6 months in Europe, and accelerated a Top 10 Biopharma company's remote patient platform from project kickoff to commercialization in less than a year. Here’s how:

  • Pre-built functionality that covers 60-80% of requirements to accelerate time to market by 6 – 24 months
  • Electronic Health Record (EHR) integrations into 500+ U.S. provider networks
  • Device-agnostic approach with 400+ medical device integrations across 50 manufacturers
  • Available in 48 countries around the globe, with additional countries planned
  • Microservices architecture for advanced security, scalability, and configurability
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Accelerate time to market

Proven, trusted digital health platform

Top 20 biopharma companies trust BrightInsight to build and launch their commercial regulated digital health solutions.

  • We are experts at building and maintaining biopharma and medtech regulated digital health products, with multiple commercial launches in the last year alone
  • We have vast experience launching high-risk Class C Software as a Medical Device (SaMD), dosing algorithms, patient support and engagement apps, chronic disease management platforms, connected combination products, diagnostics, and more
  • Our tested technology is used by patients and providers at leading healthcare systems
  • We have experience supporting regulated products across therapy areas including diabetes, respiratory, oncology, ophthalmology, obesity, hematology, immunology, neurology, and more
Case Studies
Proven trusted platform case studies

Regulatory compliant digital health infrastructure

We handle global regulatory compliance, so you don’t have to.

  • We support 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 and MDSAP (Medical Device Single Audit Program) certified
  • BrightInsight Platform Master File has been accepted by the FDA
  • Design History File and documentation follows IEC 62304 requirements
  • EC Certification allows us to run SaMD modules on the BrightInsight Platform
  • The BrightInsight QMS complies with the requirements of the EU MDR
  • Compliant with IEC 82304 which establishes best practices for software-only medical device development and software-only product development
  • One-of-a-kind cloud change control process with Google Cloud
  • Medical Device Single Audit Program (MDSAP) Certified
Regulatory Compliant Infrastructure

Watch our webinar on why a successful digital health product launch starts with a regulated infrastructure

Regulatory Webinar

Privacy and security compliance

We actively address evolving privacy and security requirements around the world.

  • Novel and turnkey privacy infrastructure to safely store Patient Identifiable Information (PII) in a compliant way, globally
  • HITRUST CSF® v9.3 Certified
  • ISO/IEC 27001:2013 Certified
  • NIST Cybersecurity Framework v1.1 Compliant
  • HDS (Hébergeur de Données de Santé) Certification
  • HIPAA and GDPR compliant
Certifications
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Insights to optimize your digital health solutions

We provide the analytics you need to optimize your digital health products.

  • Out-of-the-box dashboards with actionable insights into user behavior, Digital health program ‘stickiness’ reporting, App funnel metrics
  • Custom report creation leveraging a range of healthcare and other data sources to support evidence generation and market access negotiation
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