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Ensure FDA, EU MDR & Global Scrutiny Readiness
Compliance & Security
Operate like a regulated data organization: controls, documentation, and evidence packs that make audits and enterprise procurement smoother.
Download Governance ChecklistBook a Regulatory Readiness Review
Principle
Compliance is operational—built into the data lifecycle.
Trinzz structures your dataset workflows so they produce documentation naturally: policies, access logs, reviewer accountability, and release evidence. This reduces “audit scramble” and increases stakeholder confidence.
Least-privilege access
Role-based permissions, approvals, and controlled exports.
Documented processes
SOPs for ingestion, labeling, QC, incident response, and retention.
Evidence packs
Audit-ready artifacts exported per dataset release or project milestone.
Readiness mapping
FDA/ EU MDR/ HIPAA/ GDPR: align your operations.
Use Trinzz outputs to populate evidence for security, privacy, and governance controls. (Replace placeholders with your confirmed compliance status before publishing.)
Control areaOperational behaviorTrinzz evidence output
Access controlLeast privilege, approvals, periodic reviewRole/permission logs, access review records
Change managementDocumented changes and releasesDataset versioning, release notes, change logs
Data handlingDe-ID workflows, retention policyDe-ID SOPs, retention and deletion records
Quality & validationDefined QC and acceptance criteriaQC reports, sampling plans, acceptance thresholds
Incident readinessDefined escalation and response processIncident SOP templates, audit trail snapshots
Explore Our Trust Center
Trinzz is built on high standards
Trust Center
Security & Compliance Built for Regulated Medical AI
Healthcare AI operates under scrutiny — from regulators, hospital IT, and clinical governance teams. Trinzz is designed to meet that standard. Security and compliance are embedded into our infrastructure architecture — not layered on afterward.
Enterprise-Grade Controls
We operate under globally recognized frameworks.
These controls are continuously enforced across ingestion, validation, governance, and monitoring systems.
SOC 2 Type II
Independently audited controls for security, availability, and confidentiality.
ISO 27001
International standard for information security management systems.
HIPAA-aligned
Data handling practices aligned with HIPAA's Privacy and Security Rules.
GDPR-aligned
Protection standards aligned with GDPR data subject rights and processing requirements.
Secure by Design
Every dataset is governed, documented, and defensible.
Encrypted transit & rest
Data is protected in motion and at rest using industry-standard encryption.
Role-based access (RBAC)
Permissions scoped to role and need — no unnecessary data exposure.
Environment segregation
Strict separation between development, staging, and production environments.
Audit logging & traceability
Every action is logged and traceable across the dataset lifecycle.
Version-controlled releases
All dataset releases are versioned, documented, and reproducible.
Governance
Governance Embedded in the Data Lifecycle
Each release generates structured validation artifacts, change logs, and drift monitoring thresholds — supporting FDA submissions, MDR technical documentation, and institutional audits.
Ingest
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Validate
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Quantify
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Certify
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Monitor
Continuous Monitoring
Security does not stop at deployment.
We ensure regulated AI systems remain stable in production environments.
Distribution drift (PSI)
Continuous population stability index monitoring to detect data drift early.
Subgroup performance
Ongoing detection of performance degradation across critical subgroups.
Scanner-level shifts
Site- and equipment-level variance tracking to catch systematic changes.
Silent failure signals
Early-warning signals for model failures before they impact clinical outcomes.
Built for Enterprise
Infrastructure Enterprises Can Trust
Trinzz integrates seamlessly into enterprise MLOps and security ecosystems.
Transparent controls
Full visibility into every governance decision and access event.
Documented processes
SOPs, audit trails, and release records that satisfy enterprise procurement scrutiny.
Measurable reliability
Quantified performance scores and acceptance thresholds, not subjective assurances.
Continuous oversight
Post-deployment monitoring, drift detection, and scheduled reliability reviews.
Built for healthcare environments where failure is not acceptable.
Need an enterprise-ready security narrative?
We can help you package your controls into a buyer-friendly security and compliance response—without over-claiming.
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