ISO Certified QMS
Intrinsic Imaging's quality management system is certified by BSI to five ISO standards and has been examined in three FDA inspections, each closed with zero Form FDA 483 observations. These pages describe the system, the inspection record, each certification and how software is validated.
Quality System and Inspection Record
The only imaging core lab in the world holding five BSI ISO certifications for clinical trial imaging core lab services.
See the quality systemIntrinsic Imaging has successfully passed three FDA inspections with zero 483 observations across medical device and drug clinical trials.
See the inspection recordFive ISO Certifications
How ISO 9001 certification governs every step of an imaging endpoint at Intrinsic Imaging's core lab, from site acquisition to blinded read and data transfer.
Read about ISO 9001Why Intrinsic Imaging's core lab holds the medical device quality standard, and how ISO 13485 certification protects imaging endpoints in device trials.
Read about ISO 13485How ISO 22301 certification keeps Intrinsic Imaging's reads, adjudications and data transfers on schedule through platform, facility and reader disruptions.
Read about ISO 22301How ISO/IEC 27001 certification enforces blinding, audit trails and data separation at Intrinsic Imaging's imaging core lab.
Read about ISO/IEC 27001How ISO/IEC 27018 certification protects patient information in Intrinsic Imaging's cloud-hosted imaging workloads under HIPAA and GDPR.
Read about ISO/IEC 27018Software Validation
Explore Intrinsic Imaging’s GAMP 5 approach, FDA Part 11 requirements, imaging-specific software validation and evidence supporting sponsor oversight.
See how software is validated