Genomic Vision Obtains the Renewal of the ISO 13485 : 2016 Certification
June 23 2022 - 12:00PM
Business Wire
Regulatory News:
GENOMIC VISION (FR0011799907 – GV)
(Paris:GV). Within the compliance cycle of Standard
NF EN ISO 13485 by the subsidiary GMED (LNE Group), an independent
notified body empowered by the French National Agency for Medicines
and Health Products Safety (ANSM) for the conformity assessment of
in vitro diagnostic medical devices according to Regulation (EU)
2017/746, Genomic Vision received the decision for the renewal of
its certificate.
The renewal of this certification since 2016 confirms that
Genomic Vision's quality management system continues to meet the
specific standards required for the Design, manufacturing, sale and
associated servicing (installation and maintenance) of in vitro
diagnostic instruments and kits used for the molecular genetic
diagnosis of human pathologies.
Mohamed-Salah Garouachi, Quality & Regulatory Affairs
Director of Genomic Vision, said: "The renewal of our
certification since 2016 confirms our ability to meet regulatory
and quality requirements necessary to bring our in vitro diagnostic
medical devices to market. Indeed, the ISO 13485:2016 standard can
serve as a common basis to address regulations in different regions
like North America."
The internationally recognized ISO 13485 standard is the
reference for the implementation of a quality management system
when an organization needs to demonstrate its ability to
continually provide medical devices and associated services that
meet customer and applicable regulatory requirements.
Dominique Remy-Renou, CEO of Genomic Vision, added: "This
certification applies only to our In vitro diagnostic products
(IVD-MD). However, we apply the same level of requirements to all
our products, reflecting our commitment to customer
satisfaction."
***
ABOUT GENOMIC VISION
GENOMIC VISION is a biotechnology company developing products
and services dedicated to the analysis (structural and functional)
of genome modifications as well as to the quality and safety
control of these modifications, in particular in genome editing
technologies and biomanufacturing processes. Genomic Vision
proprietary tools, based on DNA combing technology and artificial
intelligence, provide robust quantitative measurements needed to
high confidence characterization of DNA alteration in the genome.
These tools are mainly used for monitoring DNA replication in
cancerous cell, for early cancer detection and the diagnosis of
genetic diseases. Genomic Vision, based near Paris in Bagneux, is a
public listed company listed in compartment C of Euronext’s
regulated market in Paris (Euronext: GV – ISIN: FR0011799907).
For further information, please visit www.genomicvision.com
***
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FORWARD LOOKING STATEMENT
This press release contains implicitly or explicitly certain
forward-looking statements concerning Genomic Vision and its
business. Such forward-looking statements are based on assumptions
that Genomic Vision considers to be reasonable. However, there can
be no assurance that such forward-looking statements will be
verified, which statements are subject to numerous risks, including
the risks set forth in the “Risk Factors” section of the universal
registration document filed with the AMF on April 14, 2022 under
reference number R.22-0293, as updated by the amendment filed with
the AMF on May 20, 2022, under number D.22-0293-A01, available on
the web site of Genomic Vision (www.genomicvision.com) and to the
development of economic conditions, financial markets and the
markets in which Genomic Vision operates. The forward-looking
statements contained in this press release are also subject to
risks not yet known to Genomic Vision or not currently considered
material by Genomic Vision. The occurrence of all or part of such
risks could cause actual results, financial conditions, performance
or achievements of Genomic Vision to be materially different from
such forward-looking statements. This press release and the
information contained herein do not constitute and should not be
construed as an offer or an invitation to sell or subscribe, or the
solicitation of any order or invitation to purchase or subscribe
for Genomic Vision shares in any country. The distribution of this
press release in certain countries may be a breach of applicable
laws. The persons in possession of this press release must inquire
about any local restrictions and comply with these
restrictions.
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Genomic Vision Dominique Remy-Renou CEO Tel.: +33 1 49 08
07 51 investisseurs@genomicvision.com
Ulysse Communication Press Relations Bruno Arabian
Tel.: +33 1 42 68 29 70 barabian@ulysse-communication.com
NewCap Investor Relations & Strategic
Communications Tel.: +33 1 44 71 94 94 gv@newcap.eu
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