Jul 17 2018
Aspect Imaging Ltd. has successfully obtained the ISO 13485:2016 Medical Devices Quality Management Standard certificate of registration
TEL AVIV, July 16, 2018 – Aspect Imaging, the developer and manufacturer of Embrace – the world’s first FDA-cleared and CE-approved MRI for neonatal brain and head imaging inside the neonatal intensive care unit (NICU), announced today that it has received ISO 13485:2016 certification for its Quality Management System. The company received the certification based on a comprehensive audit by BSI, a global business standards firm specializing in assisting organizations comply with ISO standards. ISO 13485:2016 requires that organizations demonstrate the ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Aspect’s new ISO 13485:2016 certification complies with the requirements of ISO 13485:2016 and EN ISO 13485:2016, and includes design, manufacture, control of sales, installation, service, and support of MRI systems.
Aspect was previously certified according to the 2003 version of the Standard, which will become obsolete in February 2019, and made the transition this year in order to be ready ahead of the transition deadline.
“We are very proud to receive the ISO 13485:2016 certificate of registration, which demonstrates Aspect Imaging’s ongoing commitment to ensuring that our products exceed the strictest quality requirements required in the neonatal MRI field. This is an important milestone following the recent FDA clearance and CE approval of our Embrace Neonatal MRI System and highlights Aspect’s robust Quality Assurance protocols which underpin our commitment to consistently deliver high quality products and services to our customers,” said Israel Citron, VP QARA, Aspect Imaging.
About Aspect Imaging
Aspect Imaging (https://www.aspectimaging.com) is a world leader in the design and development of complete, compact MRI and NMR systems using permanent magnet at 1 and 1.5 Tesla. Our unique technology platform is the basis for a wide range of products, spanning medical, preclinical, oil and gas, and advanced industrial markets. In the medical market, Aspect Imaging has several medical programs underway, including Embrace® Neonatal MRI system and WristView™ point-of-care hand and wrist MRI system which are in full production, and a dedicated Stroke MRI for the ER which is under development. In the preclinical research market, the M-series compact MRI delivers a wide variety of in vivo and ex vivo applications. Advanced industrial applications include rheological analysis of both food products and industrial drilling mud with Aspect Imaging’s Flowscan. The AI-60 NMR is used for real-time, continuous flow-through stream analysis of dense and opaque materials such as crude oil, HF, and silicon production.
For further information, contact:
VP Quality Assurance and Regulatory Affairs