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.