Intrinsic Imaging Undergoes Extensive Quality Audit – Receives Zero Observations

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Intrinsic Imaging quality management system is ISO 9001:2008 and ISO 13485:2003 certified and registered specifically for the provision of medical imaging core lab services to pharmaceutical, biotechnology, contract research and medical device organizations conducting clinical trials.

“Intrinsic Imaging has received zero audit observations from both the Food and Drug Administration and British Standard Institute,” said Todd A. Joron, BSc, MBA, President and Chief Operating Officer, Intrinsic Imaging.

Intrinsic Imaging, LLC, a medical imaging core lab specializing in providing imaging core lab services for clinical trials, announced today that it recently underwent an extensive International Organization for Standardization (ISO) audit by the British Standards Institute (BSI). At the conclusion of the audit, Intrinsic Imaging was found to be in complete compliance with all ISO 9001:2008 and ISO 13485 quality requirements and received zero observations or recommendations.

This successful ISO audit is the latest quality achievement for Intrinsic Imaging. Over the last year, Intrinsic Imaging also underwent an extensive routine audit by the Food and Drug Administration (FDA), and was found to be in complete compliance with all federal regulations and received zero 483 observations from the agency.

Intrinsic Imaging quality management system is ISO 9001:2008 and ISO 13485:2003 certified and registered specifically for the provision of medical imaging core lab services to pharmaceutical, biotechnology, contract research and medical device organizations conducting clinical trials. Its ISO certifications demonstrate the company’s ability to provide imaging core lab services that consistently meet customer and regulatory requirements.

Intrinsic Imaging was certified by the 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.

“Intrinsic Imaging has received zero audit observations from both the Food and Drug Administration and British Standard Institute,” said Todd A. Joron, BSc, MBA, President and Chief Operating Officer, Intrinsic Imaging. “Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services to pharmaceutical, biotechnology, medical device and clinical research organizations around the world.”

Intrinsic Imaging’s ISO 9001:2008 and ISO 13485:2003 quality certifications are applicable across the entire organization for all imaging core lab services for clinical trials, and are applicable to all therapeutic areas including, but not limited to, Cardiovascular, Central Nervous System, Gastrointestinal, Genitourinary, Medical Device, Musculoskeletal, Respiratory and Oncology.

About Intrinsic Imaging LLC
Located in Boston, Massachusetts and San Antonio, Texas, Intrinsic Imaging is an FDA audited, ISO 9001:2008 and ISO 13485:2003 certified, GAMP® 5 medical imaging core lab specializing in providing imaging core lab services for clinical trials. With its team of more than sixty board-certified diagnostic radiologists, robust and scalable clinical imaging technologies and our ISO certified and registered quality management systems, Intrinsic Imaging is ideally positioned to provide unprecedented imaging core lab services around the world. For more information, please visit http://www.IntrinsicCRO.com.

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Sean McIntosh
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