ISO Certified Medical Imaging Core Lab
While all companies state they are committed to quality, only Intrinsic Imaging has the most comprehensive and sophisticated quality management system in the industry.
We are the only imaging core lab to hold 5 ISO quality management system certifications specifically for providing imaging core lab services on clinical trials. We have also been audited by the FDA with Zero 483s.
Intrinsic Imaging’s quality management system is certified by the British Standards Institute (BSI). From its origins as the world’s first national standards body, BSI is the world’s largest certification body.
Most noteworthy to our Sponsors, Intrinsic Imaging ISO certified quality management systems enable us to conduct trials with unmatched operational excellence and to ensure on time quality results.
ISO Certified Quality Management System
Our FDA audited, ISO 9001, ISO 13485, ISO 22301 and ISO 27001 certified and GAMP 5 compliant quality management systems are testaments of our ongoing commitment to providing quality medical imaging core lab services.
In addition to our team, technology and therapeutic expertise, our ISO certified quality management system also provides Sponsors with high confidence in Intrinsic Imaging’s abilities as a leading medical imaging core lab.
Audited, Certified, Compliant
FDA Audited – Zero 483
ISO 9001 Certified – Quality Management Systems
ISO 13485 Certified – Medical Device Quality Management
ISO 22301 Certified – Business Continuity Management
ISO 27001 Certified – Information Security Management
GAMP® 5 Compliant – Software Validation Standards
E.U.-U.S. / Swiss-U.S. Privacy Shield Framework