Quality Management
Five ISO certifications. Three FDA Inspections.
Certified by the British Standards Institution (BSI), Intrinsic Imaging's quality management system is among the most comprehensive and sophisticated in the industry. Intrinsic Imaging is the only organization in the world to hold five International Organization for Standardization (ISO) certifications specifically for providing imaging core lab services for clinical trials.
Quality Systems
“Quality cannot be inspected into a clinical trial; it must be engineered into every system that touches the data. Integrity that cannot be demonstrated is integrity that does not exist.”
Huy Nguyen, Vice President, Imaging Technology
ISO 9001
Quality Management Systems
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.
ISO 13485
Medical Devices — Quality Management
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 medical device development and submission.
ISO 22301
Business Continuity Management
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.
ISO 27001
Information Security Management
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.
ISO 27018
Protection of PII in Public Clouds
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.
Technology, Software Validation and Imaging Data Integrity
Our clinical trial imaging technology connects secure image intake, quality control, blinded central review and data delivery. A risk-based software validation approach links intended use, verification evidence and controlled change throughout that workflow.
Quality Controls Throughout the Imaging Data Lifecycle
Our quality system connects documented procedures with study-level controls. Sponsors can review how acquisition, central reading, data handling and issue resolution are governed, rather than relying on certification names alone.
Document Control, Training and Change Management
Study documents, acquisition guidelines and reading instructions are version controlled. Personnel train on their assigned tasks, and changes are reviewed for their effect on sites, readers, systems and endpoint interpretation. Approved changes have documented implementation and communication steps.
Deviation Management and Corrective Action
Quality issues are recorded, assessed for impact and escalated according to their significance. Root-cause review and corrective and preventive action address recurring problems such as incomplete acquisitions, reader drift or data-transfer discrepancies. Follow-up checks assess whether the action resolved the issue.
Data Integrity, Blinding and Continuity
Access controls separate study roles and protect blinded assessments. Traceable records connect source images to quality review, reader decisions, adjudication and data release. Business-continuity planning addresses critical activities and recovery responsibilities; study-specific arrangements define how disruptions are communicated to sponsors.
Quality you can audit
Request our certification documentation or discuss QMS requirements for your trial.