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Brainstorme – Trust Center

Everything you need to know about security and compliance at Brainstorme.

Compliance overview

Current compliance status across frameworks.

  • FDA 21 CFR Part 11

    21 CFR Part 11

    1997 (as amended); FDA Scope & Application guidance 2003

    Compliant
  • ISO 27001

    ISO 27001

    2022

    In progress
  • SOC 2 (AICPA)

    SOC 2

    1

    In progress
  • ISO 13485 / FDA QMSR

    ISO 13485:2016; FDA QMSR (21 CFR 820, effective 2026)

    In progress
  • GDPR

    Regulation (EU) 2016/679

    In progress
  • HIPAA

    45 CFR Parts 160, 162, 164

    In progress

Security Posture

An overview of security measures in place.

Access control and authorization

  • One or more annual third-party audit(s)
  • Formal information security policies published
  • Subprocessors list available
  • Documented security control program
  • Deletes customer data on request

Infrastructure Security

  • Has a disaster recovery plan