The British Standards Institute (BSI) has awarded ISO 13485:2003 quality certification to Intrinsic Imaging's medical devices.
The ISO 13485:2003 certification, FM 587032, was accorded based on the company’s ability to provide medical imaging core lab services that meet customer and regulatory requirements.
In addition, the company has obtained ISO 9001:2008 certification in November 2011 and has implemented ISPE GAMP5 medical imaging core lab services in March 2012.
The company said ISO 9001:2008 and ISO 13485:2003 certifications are applicable to all therapeutic areas including, but not limited to, cardiovascular, central nervous system, GI & genitourinary, medical device, musculoskeletal, respiratory and oncology.
Intrinsic Imaging president and COO Todd Joron said , "Intrinsic Imaging is an FDA audited, ISO 9001:2008 and ISO 13485:2003 certified and GAMP 5 medical imaging core lab specializing in providing imaging core lab services for clinical trials."