Co-Diagnostics, Inc. to Undergo ISO 13485:2016 Audit
August 10 2017 - 7:30AM
Business Wire
Audit to prepare for eventual sales into the
US market
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, will
be undergoing a Stage II Upgrade Assessment Audit to ISO
13485:2016.
The International Organization of Standards (ISO) is a
non-government entity comprised of academic and industry
professionals which certifies that companies are compliant with
industry-standard best practices in their production and
operations. ISO 13485:2016, the international standard for medical
device quality management systems, differs from the 2003 version of
the standard in its increased emphasis on risk management. It also
harmonizes more closely the quality system regulations found in FDA
21 CFR Part 820, the law for medical device companies manufacturing
or selling products for the US. The audit will be performed this
week by DQS Inc., one of the leading global certification bodies
for management systems.
Dwight Egan, Co-Diagnostics CEO, remarked, “The risk management
activities required by the new 13485:2016 standard parallel our
commitment to producing high-quality products that meet and exceed
customer expectations. Although we are not required to upgrade to
the new standard until March 2019, this standard helps us realize
our company policy and helps us prepare for our eventual entry into
the US market. We look forward to the credibility that this
upgraded certification will bring to our company.”
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/20170810005395/en/
Co-Diagnostics Investor RelationsSeth Egan,
801-438-1036investors@codiagnostics.com
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