generated: '2026-07-20'
method: searched
source: >-
  https://proscia.com/press-releases/proscia-achieves-soc-2-type-ii-certification-strengthening-enterprise-trust/
  ; https://proscia.com/press-releases/proscia-achieves-iso-27001-security-certification/
  ; https://proscia.com/concentriq-ap-dx/
standards:
- id: soc2-type-ii
  conforms: true
  evidence: Proscia achieved SOC 2 Type II certification (press release).
- id: iso-27001
  conforms: true
  evidence: Proscia achieved ISO 27001 information-security-management certification (press release).
- id: iso-13485
  conforms: true
  evidence: Proscia maintains ISO 13485 medical-device quality-management compliance.
- id: hipaa
  conforms: true
  evidence: Concentriq aligns to HIPAA privacy standards; role-based access, audit logs, encryption at rest/in transit.
- id: gdpr
  conforms: true
  evidence: Concentriq aligns to GDPR privacy standards.
- id: fda-510k
  conforms: true
  evidence: Concentriq AP-Dx received FDA 510(k) clearance for primary diagnosis.
- id: ce-ivdr
  conforms: true
  evidence: Concentriq AP-Dx is CE-IVDR marked for primary diagnosis in Europe.
- id: saml-sso
  conforms: true
  evidence: Enterprise SAML SSO federation (Okta, Microsoft/Entra) documented in release notes.
- id: dicom
  conforms: true
  evidence: Concentriq supports DICOM whole-slide image formats and AWS HealthImaging integration.