HeartIT’s Quality System Receives Certification Under ISO 13485
August 10, 2016 – Heart Imaging Technologies,LLC (HeartIT) today announced that an internationally-recognized standards body, BSI Group, has certified that HeartIT’s Quality Management System (QMS) meets or exceeds the requirements for the design and manufacture of medical devices. The specific standard used by BSI was International Organization for Standardization (ISO) standard 13485.
HeartIT’s new ISO 13485 Certificate of Registration relates to the “Design, manufacture, installation and servicing of medical image workstation software for analysis of images in DICOM format for use in diagnosis of heart physiology and function, and generating and reviewing reports.”
According to HeartIT’s Quality Unit Head, Susan Adams-Judd, “ISO 13485 certification is a major milestone for our QMS, which underwent a complete overhaul in early 2016 specifically to prepare for the BSI certification process. Emergo was our consulting company for the overhaul, and they helped us introduce a new level of professionalism to our processes. We’re already seeing improvements in the quality of our software releases, now that our new quality system has become fully operational.”
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About Heart IT
Founded in 2000 and headquartered near North Carolina’s Research Triangle Park, Heart IT is a global leader in the medical image web enablement field. Heart Imaging Technologies was the first company to offer a FDA approved zero foot-print medical image workstation which has become the precedent for other companies seeking FDA approval. HeartIT provides web-based medical image management technology and services to health care systems, large hospitals and private clinics as well as drug and device companies sponsoring multi-center clinical trials. Worldwide, Heart Imaging Technologies solutions provide secure web browser access to over one billion medical images. For more information visit our website at www.heartit.com.