Quality
ISO Certified
Intrinsic Imaging operates the most comprehensive and sophisticated quality management system in the industry.
Quality is not simply a compliance function at Intrinsic Imaging—it is the foundation upon which every clinical trial, imaging endpoint, independent review, and regulatory deliverable is built. Intrinsic Imaging has developed one of the most comprehensive and sophisticated integrated quality management systems in the imaging core lab industry, specifically designed to address the scientific, operational, regulatory, information-security, and business-continuity requirements of global clinical trials.
Certified by the British Standards Institution (BSI), Intrinsic Imaging is the only imaging core lab in the world to hold five ISO certifications specifically for the provision of imaging core lab services for clinical trials: ISO 9001 for Quality Management Systems, ISO 13485 for Medical Device Quality Management, ISO 22301 for Business Continuity Management, ISO/IEC 27001 for Information Security Management, and ISO/IEC 27018 for the protection of personally identifiable information in public cloud environments.
Together, these internationally recognized standards provide an integrated framework governing the processes, technologies, personnel, data, and controls that support Intrinsic Imaging’s Phase I–IV pharmaceutical and biotechnology trials, Class I–III medical device studies, and complex artificial intelligence and medical imaging software validation programs.
Intrinsic Imaging’s commitment to quality extends far beyond certification. Its quality framework is embedded throughout the clinical trial lifecycle—from protocol and imaging charter development, site qualification and image acquisition standardization through image receipt and quality control, blinded independent central review, adjudication, quantitative analysis, database lock, and regulatory-ready data delivery.
The system is designed to promote consistency and reproducibility, maintain data integrity and traceability, protect confidential sponsor and patient information, ensure continuity of critical imaging operations, and support compliance with applicable global regulatory requirements. This disciplined approach has been tested not only through independent ISO certification audits, but also through three FDA Bioresearch Monitoring Program inspections, each completed with zero Form FDA 483 observations.
By integrating internationally recognized quality standards with deep clinical, scientific, technological, and regulatory expertise, Intrinsic Imaging provides sponsors with a quality infrastructure designed to reduce operational and regulatory risk, protect the integrity of imaging endpoints, and produce reliable, audit-ready evidence for some of the world’s most complex clinical development programs.
What Each Certification Means for Your Trial
| Standard | Scope | What it protects in your trial |
|---|---|---|
| ISO 9001 | Quality management systems | Consistent, documented processes across every study—from imaging charter development through database lock—so reads and deliverables are reproducible and audit-ready. |
| ISO 13485 | QMS for medical device trials | A quality system built to medical-device regulatory expectations, supporting Class I–III medical device trials and AI/CAD software validation programs. |
| ISO 22301 | Business continuity management | Continuity of critical imaging operations—image receipt, quality control, and independent review keep running even through disruption, so your read schedule holds. |
| ISO/IEC 27001 | Information security management | Systematic controls protecting confidential sponsor data, imaging datasets, and trial results across our imaging core lab services and imaging CRO operations against unauthorized access or loss. |
| ISO/IEC 27018 | Personally identifiable information on the cloud | Dedicated safeguards for patient privacy in cloud environments, protecting identifiable information within imaging data transferred from sites worldwide. |
ISO Certified — a foundation of quality and trust.
Applying the Five ISO Certifications to Your Study
The certifications work together across the imaging lifecycle. Study procedures translate that framework into controlled acquisition, review, information handling and service continuity.
A Coordinated Quality and Security Framework
Quality and medical-device controls govern documented methods and traceable service delivery. Information-security and cloud-privacy controls address access, processing and handling of imaging data. Business-continuity controls address critical operations and disruption response. Each study’s charter and operating plan define how these controls apply to its imaging workstream.
Documentation for Sponsor Due Diligence
Sponsors can request certification documentation and discuss study-specific audit requirements. Due diligence can review certificate scope alongside relevant procedures, training, change control and continuity arrangements. Certification does not replace protocol-specific validation or confer regulatory approval on a sponsor’s drug, device or AI product.