Standards, Regulations & Certifications

To help our biopharma and medtech customers with compliance and reporting, we share information, best practices, and easy access to documentation. Our BrightInsight Platform regularly undergoes independent verification of security, privacy, and compliance controls, achieving certifications against global standards to earn your trust. We’re constantly working to expand our coverage.

ISO 13485:2016


Medical device quality management systems.

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ISO/IEC 27001


Managing information security risks.

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HITRUST CSF®


Industry agnostic certification framework for regulatory compliance and risk management.

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HIPAA


Protecting health
information.

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GDPR


Protecting personal information in compliance with stronger EU data protection laws.

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PRIVACY SHIELD


A framework for complying with EU General Data Protection Regulation (GDPR) requirements.

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