ISSYS Achieves Both ISO-13485:2003 And EN-13980:2002 Quality Standards: Ypsilanti-based Integrated Sensing Systems Inc., or Issys as the firm is called, said Wednesday it had received certifications for both ISO-13485:2003 and EN-13980 quality standards in addition to ISO-9001:2008. ISO-13485-2003 is an internationally recognized quality standard for the development and manufacturing of medical devices to provide harmonization of the Quality management system in the international market. ISSYS is registered with FDA as a medical device manufacturer with the FDA-listing-number of 3005694613. Additionally, ISSYS is employing other high-level quality guidelines including FDA QSR 21 CFR 820 and Directives 90/385/EEC and 93/42/EEC. ISSYS requires these standards for the commercialization of its miniature, wireless, batteryless, pressure sensing implants for monitoring chronic diseases, such as congestive heart failure, structural heart diseases, hydrocephalus, and traumatic brain injuries. EN-13980:2002 is required for the development and production of ATEX/IEC Ex approved intrinsically safe products. ISSYS utilizes this standard for the commercialization of its fluidic sensors particularly in the fuel manufacturing and fuel custody transfer applications. ISSYS is also a registered ITAR (International Traffic in Arms Regulations) organization as a manufacturer and exporter with the Office of Defense Trade Controls Compliance and Registration Division with registration code of M30151. Issys Provides advanced micro-electro-mechanical systems (MEMS) technologies for industrial and medical devices, microfluidic and scientific analytical sensing applications. Founded in 1995, ISSYS is one of the oldest independent MEMS companies in the United States. ISSYS operates a “full manufacturing under one roof,” multi-million-dollar, state-of-the-art MEMS fabrication facility located near Ann Arbor, Michigan. ISSYS’ quality system is certified to ISO 9001:2008 for industrial products, ISO13485:2003 for medical devices, and EN-1980:2002 for ATEX/IEC Ex approved intrinsically safe products. More at www.mems-issys.com.
Awards And Certifications From December 5
December 5, 2012 3:47 PM
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