Five ISO certifications. One imaging core lab.

The global benchmark for quality management. Governs how every imaging core lab process — from protocol design and site qualification to independent reads and database lock — is documented, monitored, and continuously improved, ensuring consistent, audit-ready delivery on every clinical trial.

The medical-device QMS standard recognized by FDA, EMA, and global regulators. Applied to our imaging workflows, it ensures the systems, software, and processes supporting medical device clinical trials (510(k), De Novo, PMA) meet the rigor required for regulated device development and submission.

Certifies our ability to maintain imaging operations through disruption. Redundant reading infrastructure, validated DR procedures, and tested continuity plans ensure independent reads, adjudications, and data transfers stay on schedule — protecting trial timelines and regulatory milestones.

Governs how we protect sponsor data, blinding, and patient imaging across the full chain of custody. End-to-end controls over access, transmission, encryption, and audit logging keep DICOM data, reads, and trial endpoints secure and 21 CFR Part 11 aligned.

Extends our information security program to cloud-hosted imaging workloads. Ensures personally identifiable information embedded in imaging data is handled in line with global privacy expectations (GDPR, HIPAA), with documented controls over processing, storage, and sponsor data ownership.