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ISSYS Has Received Certification for Both ISO-13485:2003 and EN-13980:2002 Quality Standards

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Integrated Sensing Systems

391 Airport Ind. Dr., Ypsilanti, MI, 48198, USA

Original Press Release

ISSYS Has Received Certification for Both ISO-13485:2003 and EN-13980:2002 Quality Standards

Press release date: December 5, 2012

YPSILANTI, MI - Integrated Sensing Systems, Inc. (ISSYS) announced that it has 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 (CHF), structural heart diseases, hydrocephalus, and traumatic brain injuries (TBI).

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 (CRD) with registration code of M30151.

Dr. Nader Najafi, ISSYS President and CEO, stated that, "among the US. MEMS-based companies, ISSYS is in a distinguished position for high-quality manufacturing at both the MEMS and system-level design and production. To the best of our knowledge, ISSYS is the only MEMS-based company in the US., who is certified for both ISO-13485:2003, EN-13980 and ISO-9001-2008 quality standards."

ISSYS Background:

ISSYS is a leader in advanced 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 US. 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-13980:2002 for ATEX/IEC Ex approved intrinsically-safe products. ISSYS is a vertically integrated company dedicated to developing and manufacturing system-level products based on MEMS technology (MEMS Inside). Please visit: http://www.mems-issys.com/

Contact: Nader Najafi, PhD
President & CEO
Integrated Sensing Systems, Inc.

391 Airport Industrial Dr.
Ypsilanti, MI 48198
(734) 547-9896 Ext 103
Fax (734)-547-9964
nader@mems-issys.com

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