
Everything you need to know about security and compliance at Brainstorme.
Current compliance status across frameworks.
21 CFR Part 11
1997 (as amended); FDA Scope & Application guidance 2003
ISO 27001
2022
SOC 2
1
ISO 13485 / FDA QMSR
ISO 13485:2016; FDA QMSR (21 CFR 820, effective 2026)
GDPR
Regulation (EU) 2016/679
HIPAA
45 CFR Parts 160, 162, 164
An overview of security measures in place.