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.
Intrinsic Imaging’s registration certificates were issued by British Standards Institute (BSI), one of the world’s largest certification bodies. From its origins as the world’s first national standards body, BSI is among the most respected and reputable quality management systems certification bodies in the world and is the largest certifier for both the United Kingdom and North America.
Our quality management system is FDA audited, ISO 9001, ISO 13485, ISO 22301 and ISO 27001 certified and GAMP® 5 compliant.
Most noteworthy to our Sponsors, Intrinsic Imaging ISO certified quality management systems enables us to conduct trials with unmatched operational excellence 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