Digital Health Platform • Software as a Medical Device (SaMD) • Digital Health Algorithms

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 platform designed under a Quality Management System to support global security, privacy, and regulatory requirements.

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

Accelerate time to market

We helped Roche launch a Software as a Medical Device dosing calculator for hemophilia A in 6 months in Europe, and accelerated AstraZeneca’s disease management 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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Proven, trusted 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

Regulatory compliant 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

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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Brightinsight platform split real time intelligence

WHITE PAPER: Digital Health Platform Buy vs. Build Analysis

Read our white paper, with insights from AstraZeneca, Roche, and CSL Behring, for recommendations on launching a scalable digital health platform that meets your company’s needs.

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