EUROBIO SCIENTIFIC CERTIFIED ISO 13485 V2016

Eurobio Scientific has successfully upgraded its quality management systems
in order to continue justifying CE marking
of its products beyond 2019 
     

Paris, October 23, 2018 - 5.45 pm

Eurobio Scientific (FR0013240934, ALERS, eligible PEA-PME), leading French group in the field of specialty in vitro medical diagnostics, announces that it has obtained the ISO 13485v2016 certificate on September 19, 2018.

Eurobio Scientific managed to merge the ISO certificates of EUROBIO (Les Ulis) and INGEN (Chilly Mazarin) within an extremely short timeframe, thus demonstrating a very good collaboration of the teams and the Group's regulatory know-how.

In particular, the Group has implemented a strong Quality Policy, which consists in developing, implementing and continuously improving the quality management system that meets the standards NF EN ISO 13485: 2016, mandatory since March 2019 for CE marking of medical devices. Eurobio Scientific thus shows that it is able to meet both the upcoming regulatory and its customers' requirements.

This quality system's robustness has been audited and validated by the French notified body LNE GMED.

"These conclusive results, less than a year after the merger between Eurobio and InGen, demonstrate the Group's commitment to be fully compliant with the regulations. This certification is a guarantee of quality for our customers and lays a solid foundation for the implementation of the new regulation on medical devices. I wanted to thank all the teams for this great achievement", commented Denis Fortier, General Manager of Eurobio Scientific.

Upcoming financial meeting
2018 Turnover: January 29, 2019

About Eurobio Scientific
Eurobio Scientific (ex Diaxonhit) is a key player in the field of specialty in vitro diagnostics. It is involved from research to manufacturing and commercialization of diagnostic tests in the fields of transplantation, immunology and infectious diseases, and sells instruments and products for research laboratories, including biotechnology and pharmaceutical companies. Through many partnerships and a strong presence in hospitals, Eurobio Scientific has established its own distribution network and a portfolio of proprietary products in the molecular biology field. The Group has approximately 120 employees and two production units based in the Paris region and in the United States.

 

For more information, please visit: www.eurobio-scientific.fr

 

The company is publicly listed on the Euronext Growth market in Paris
Euronext Growth BPI Innovation, PEA-PME 150 and Next Biotech indices.
Symbol : ALERS - ISIN Code: FR0013240934  -  Reuters : ALERS.PA  - Bloomberg : ALERS:FP

 

 
Contacts


Eurobio Scientific Group
Denis Fortier, General Manager
Hervé Duchesne de Lamotte, General Manager
Tel. +33 1 69 79 64 80

 
Calyptus
Sophie Levesque / Mathieu Calleux
Investor Relations
Tel. +33 1 53 65 68 68 - eurobio-scientific@calyptus.net

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