Calibrex Technologies, Inc. Granted ISO 13485:2016 Certification

By: PRLog
RENO, Nev. & RESEARCH TRIANGLE PARK, N.C. - Oct. 3, 2018 - PRLog -- Calibrex Technologies, Inc.  ("Calibrex" or the "Company"), a life sciences, biotech, and clinical diagnostics company with substantial experience in medical devices, custom/OEM laboratory automation and innovative labware, has been granted the most recent ISO 13485: 2016 certification following successful completion of an audit of its quality management system. To be certified, companies must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

The audit was performed in September by NSF International Strategic Registrations (NSF-ISR), a leading global certification body, known for its superior technical expertise and customer satisfaction. Through the highest level of integrity, the NSF-ISR mark is recognized as the gold standard of the certification industry.  Founded in 1944, NSF operates in more than 175 countries, and is committed to protecting human health and safety worldwide.

The International Organization of Standards (ISO) is a non-government entity comprised of academic and industry professionals that certifies that companies are compliant with industry-standard best practices in their production and operations. Medical device manufacturers are required to update their quality systems to the new standard by March 2019, in order to remain in compliance. The 2016 standard for quality management systems places an increased emphasis on risk management and harmonizes more closely with the quality system regulations found in FDA 21 CFR Part 820, the law for medical device companies manufacturing or selling products for the United States and international markets. The Company's certificate is valid until October 2021 with a scope of Design and Development of OEM laboratory equipment for BioPharma, Forensics, and Clinical Laboratories.

Robert Skach, Calibrex Founder/CEO, remarked: "Continuing our heritage of advancing our quality management system and best practices emphasis on risk management, is another important step in the direction of ensuring that Calibrex's products meet the high standards of quality expected by U.S. and international regulators, and our customers. This certification represents another important milestone for our company and reflects the focus we have on risk-based decision making throughout our organization, with a commitment to safety and providing high-quality products.  We look forward to the continuing credibility that will accompany our willingness to comply with the same standards met by much larger companies with greater reach and resources."

About Calibrex Technologies, Inc.:

Calibrex Technologies, Inc., a Nevada corporation with offices in Reno, NV and Research Triangle Park, NC., is a life sciences and clinical diagnostics company.  Using advanced material science, Calibrex has developed and manufactures custom laboratory automation instruments and components, and innovative labware used for testing via the detection and/or analysis of nucleic acid molecules (DNA or RNA) among others, with applications in bio-pharma, forensics, and clinical laboratories.  Our X-Factor™ Laboratory Automation and X-Factor Labware™ offers our customers the ability to move from proof-of-concept, to validation and to market quickly and efficiently.

For more information, visit or call 775.229.8978.

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