With this latest quality achievement, Intrinsic Imaging has the most comprehensive and sophisticated quality management system of all imaging core labs.
Bolton, MA, San Antonio, TX, March 9, 2017
Intrinsic Imaging, LLC, an FDA audited medical imaging core lab, proudly announces today that its quality management system has attained certification to ISO 27001 for Informational Security Management.
Intrinsic Imaging is certified by the British Standards Institute (BSI), the world’s largest and most respected National Standards Body. Their certification is specifically for ensuring informational security while providing services on Phase I, II and III Clinical Trials and Class I, II and III Medical Device trials.
Intrinsic Imaging’s ISO 27001 certification demonstrates the company’s ability to reliably and effectively protect all informational assets during clinical trials. This includes protection of all activities, functions, services, partnerships and supply chains from a disruptive informational security incident.
In its ongoing commitment to providing imaging core lab services with exceptional quality, Intrinsic Imaging’s quality management system is also ISO 9001, ISO 13485 and ISO 22301 certified and GAMP5 compliant.
“Intrinsic Imaging is committed to quality and to ensuring our Sponsors’ clinical trials are executed efficiently and without disruption,” said Todd A. Joron, BSc, MBA, President & COO. “With this latest quality achievement, Intrinsic Imaging has the most comprehensive and sophisticated quality management system in the imaging core lab industry.”
In addition to its ISO certification portfolio, Intrinsic Imaging has also been extensively audited by the Food and Drug Administration (FDA). In its most recent audit, Intrinsic Imaging received zero 483 observations and was in complete compliance with all federal regulations.
About Intrinsic Imaging
Located in Bolton, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001:2008 and ISO 13485:2003 certified, GAMP® 5 compliant medical imaging core lab specializing in providing imaging core lab services for clinical trials. Its comprehensive medical imaging core lab services include, but are not limited to, expert radiologist consultation, protocol and charter development, site qualification, training and management, as well as image acquisition, processing and detailed radiologic analysis.
Intrinsic Imaging has more than sixty full-time, board-certified diagnostic radiologists on staff that have sub-specialization in all therapeutic areas including, but not limited to, Cardiovascular, Central Nervous System, Gastrointestinal & Genitourinary, Medical Device, Musculoskeletal and Oncology.