BAGNEUX, France, June 23, 2022–(BUSINESS WIRE)–Regulatory News:
GENOMIC VISION (FR0011799907 – GV, PEA-PME eligible) (Paris:GV). As part of compliance with the cycle of its certification to the ISO 13485: 2016 standard by the GMED of the LNE group, an independent French organization Notified by the National Agency for the Safety of Medicines and Health Products (ANSM) for the evaluation of compliance of in vitro diagnostic medical devices under Regulation (EU) 2017/746, Genomic Vision has received the decision to renew its certificate.
Maintaining this certification since 2016 confirms that Genomic Vision’s quality management system continues to meet the specific standards required for the design, manufacture, sale and associated services (installation and maintenance) of instruments and kits. in vitro diagnostics used for the molecular genetic diagnosis of human pathologies.
Mohamed-Salah Garouachi, Quality & Regulatory Affairs Director at Genomic Vision, explains:
” Maintaining our certification since 2016 confirms our ability to meet the regulatory and quality requirements necessary for the marketing of our in vitro diagnostic medical devices. Indeed, the ISO 13485 Standard can serve as a common base to meet the regulations of different regions, such as North America. »
The internationally recognized ISO 13485 standard is the benchmark for setting up a quality management system when an organization must demonstrate its ability to regularly provide medical devices and associated services that comply with customer requirements and applicable regulatory requirements.
Dominique Remy-Renou, Chairman of the Management Board of Genomic Vision, adds: “This certification only applies to our in vitro diagnostic products (DM-DIV). However, we apply the same level of requirements to all of our products, thus reflecting our commitment to the satisfaction of our customers. »
ABOUT GENOMIC VISION
GENOMIC VISION is a biotechnology company that develops 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 the technologies of editing of the genome and in bioproduction processes. GENOMIC VISION’s proprietary tools based on DNA combing technology and artificial intelligence, provide robust quantitative measurements needed for reliable characterization of DNA alterations in the genome. These tools are notably used to monitor DNA replication in cancer cells, for the early detection of cancers and for the diagnosis of genetic diseases. Based in Bagneux, in the Paris region, the company has approximately 30 employees. GENOMIC VISION is listed on the regulated market of Euronext in Paris, Compartment C (Euronext: GV – ISIN: FR0011799907).
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This press release contains implicitly or expressly forward-looking statements relating to Genomic Vision and its activities. Genomic Vision believes that these forward-looking statements are based on reasonable assumptions. However, no guarantee can be given as to the achievement of the forecasts expressed in these forward-looking statements which are subject to risks, including those described in the “Risk Factors” section of the Universal Registration Document filed with the Autorité des Marchés Financiers (AMF) on April 14, 2022, under registration number D. 22-0293, updated by the amendment filed with the Autorité des Marchés Financiers (AMF) on May 20, 2022, under number D .22-0293-A01, available on the company’s website (www.genomicvision.com) and changes in economic conditions, financial markets and markets in which Genomic Vision is present. The forward-looking statements contained in this press release are also subject to risks unknown to Genomic Vision or that Genomic Vision does not consider material at this date. The realization of all or part of these risks could cause the actual results, financial conditions, performance or achievements of Genomic Vision to differ materially from the results, financial conditions, performances or achievements expressed in these forward-looking statements.
This press release and the information it contains do not constitute, nor shall they be interpreted as an offer or invitation to sell or subscribe, or the solicitation of any order or invitation to buy or subscribe to Genomic Vision shares. in any country. The distribution of this press release in certain countries may constitute a violation of the legal provisions in force. Persons in possession of the press release must therefore inform themselves of any local restrictions and comply with them.
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Genomic Vision obtains the renewal of its ISO 13485: 2016 certification
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