Co-Diagnostics, Inc. Granted ISO 13485:2016 Certification
November 02 2017 - 7:30AM
Business Wire
Co-Diagnostics, Inc. (NASDAQ: CODX) (“Co-Diagnostics” or
the “Company”), a molecular diagnostics company with a unique,
proprietary platform for the development of diagnostic tests, has
been granted ISO 13485:2016 certification following successful
completion of an audit of its quality management system. The audit
was performed in August by DQS Inc., one of the leading global
certification bodies, and included a review of the Company’s
quality management system to ensure compliance with the newest
version of the ISO 13485 standard.
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 US, and the European
Commission’s new IVDR 2017/746 for in-vitro diagnostics. The
Company’s certificate is valid until September 2020 with a scope
that encompasses the design and manufacture of medical device
products for the handling, stabilization, separation, purification,
amplification, and detection of nucleic acids.
Dwight Egan, Co-Diagnostics CEO, remarked “Harmonizing with the
US and European Commission’s emphasis on risk management is an
important step in the direction of ensuring Co-Diagnostics’
products meet the high standards of quality expected by
international regulators, and customers. We look forward to the
credibility that will accompany our willingness to comply with the
same standards met by much larger companies with greater reach and
resources.”
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular
diagnostics company that has developed and intends to manufacture
and sell reagents used for diagnostic tests that function via the
detection and/or analysis of nucleic acid molecules (DNA or RNA),
and to sell diagnostic equipment from other manufacturers as
self-contained lab systems.
Forward-Looking Statements:
This press release contains forward-looking statements.
Forward-looking statements can be identified by words such as
"believes," "expects," "estimates," "intends," "may," "plans,"
"will" and similar expressions, or the negative of these words.
Such forward-looking statements are based on facts and conditions
as they exist at the time such statements are made and predictions
as to future facts and conditions. Readers of this press release
are cautioned not to place undue reliance on any forward-looking
statements. The Company does not undertake any obligation to update
any forward-looking statement relating to matters discussed in this
press release, except as may be required by applicable securities
laws.
Disclaimer:
This news release does not constitute an offer to sell or a
solicitation of an offer to buy the securities described herein,
nor shall there be any sale of these securities in any state or
jurisdiction in which such an offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction.
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version on businesswire.com: http://www.businesswire.com/news/home/20171102005565/en/
Co-Diagnostics, IncAndrew Benson, Investor
Relations801-438-1036investors@codiagnostics.com
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