Rock-solid security. Built for compliance.

SOC 2 Type II is an independent audit of how a company's controls operate over a period of time, not on a single day. Sirona runs an active SOC 2 Type II program, and the attestation report is available under NDA for your security team to review.

Yes. Sirona is an FDA Class II device company, and the reporter is part of a Class I device product. Sirona Medical is an FDA-registered medical device establishment. The Sirona Advanced Imaging Suite — multi-planar reconstruction and PET-CT fusion with quantitative SUV analysis — received FDA 510(k) clearance in October 2025.

AES-256 for data at rest and TLS 1.2+ with strong ciphers for browser and API traffic. Site integrations connect over encrypted VPN tunnels, and keys are managed in AWS KMS.

HIPAA requirements are built into the platform: role-based access controls, audit logging of changes to clinical information, and encryption at rest and in transit. You sign one BAA, with Sirona. HIPAA controls are assessed as part of our SOC 2 Type II program. Beyond the audit trail, Sirona captures detailed application event data, including session replays of how the application was used. We are making more of that data available through the Dashboard, and over time through the SDK and APIs.

Sirona runs a routine third-party security testing program — external security researchers test the platform for vulnerabilities. Results drive vulnerability management, patches, and incident response. Continuous validation, not a one-time audit.

Sirona is pursuing EU MDR (Medical Device Regulation) certification as the foundational pathway for our international expansion, with ISO 13485 also in progress. These pathways will unlock market access across the UK, EU, South Africa, and UAE as expansion rolls out.