Evanston, IL, Jan. 26, 2016 (GLOBE NEWSWIRE) -- Ohmx Corporation, a diagnostics company developing a versatile POC testing system with innovative electrochemical detection technology, has achieved ISO 13485:2003 Certification for the design, development, and manufacturing of detection reagents for use in in vitro diagnostics.
ISO 13485:2003 describes the requirements for a quality management system to create medical devices that consistently satisfy customers and regulatory requirements. Certification to the international standard shows a commitment to maintaining and improving a system designed to provide a safe and effective product.
To become certified, a company must demonstrate the effective implementation of the requirements of the standard to an independent, accredited organization. In December of 2015, Ohmx completed the certification audit process with The British Standards Institution (BSI), an internationally recognized certification body, and has been approved for certification. Ohmx's certificate was issued on January 22, 2016.
“This certification is an important step for Ohmx,” said Jorge Castaños, VP of Quality Systems and Regulatory Affairs. “It lets the world know that the products manufactured for diagnostic assays will be closely controlled, carefully tested, and ultimately safe and effective for doctors and patients who depend on them for reliable diagnosis.”
About the Company:
Based in Evanston, IL, Ohmx is developing an automated standalone system which applies innovative and proprietary electrochemical detection to Point of Care (POC) tests. The versatile analyzer can quickly and accurately detect protein, small molecule, and DNA targets, providing reliable results clinicians and emergency personnel need to diagnose diseases and manage chronic conditions. The Ohmx platform uses a low-volume sample yet provides rapid results comparable to central laboratory testing. In addition, Ohmx is developing a biomarker for prognosis of prostate cancer, aimed at enabling physicians and patients to make an informed decision on whether active surveillance is an appropriate option.
This press release contains forward-looking statements that involve a number of risks and uncertainties. Our actual results could differ materially from the results identified or implied in any forward-looking statement. These statements are based on our views as of the date they are made with respect to future results or events. The Company does not undertake to publicly update or revise its forward-looking statements even if experience or future changes make it clear that any projected results or events expressed or implied therein will not be realized.