BrightInsight

San Jose, CA · United States

Digital Health & DTxmid

Specialization: Regulated digital health platform for biopharma and medtech

Key Differentiator

Managed platform built under a QMS for regulated devices, combination products, apps and SaMD.

Core Services

Regulated digital health platform; Software as a Medical Device (SaMD) development; Connected diagnostics; Combination product and app data management; Consulting

Capabilities

SaMD built to IEC 62304Data capture from regulated devicesConnected diagnostics platformHIPAA and GDPR compliant hostingDigital immunology solutions

Market Intelligence

Raised a $40M Series B led by Insight Partners in 2020, with New Leaf, Eclipse and Flex as investors. CSL Behring is a named customer.

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