Please contact IVA for:
Phone: +33 (0)4 66 79 67 87
Fax: +33 (0)4 66 79 67 50
Parc Marcel Boiteux
30200 Codolet, France
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At Cisbio Bioassays, quality is considered to be the essential element in ensuring product efficiency and in guaranteeing patient and user safety.
We know that the stakes are high: on-going upgrades of our products and services reinforce our customers' confidence, and in parallel we implement organizational improvements oriented towards customer satisfaction, with higher levels of competitiveness through mastery of our organization and of non-quality costs.
Cisbio Bioassays is certified ISO 9001 V2008 , ISO 13485 V2003 and NF EN ISO 13485 : 2012 the latter standard defining the requirements specific to medical devices (and more specifically for In Vitro Diagnosis).
Cisbio's objective is to offer the worlds leading RIA portofolio for In Vitro Diagnosis and to be your partner of choice of medical devices in ELISA for specialized testing. Setting this objective has enabled Cisbio Bioassays to identify quality as a vital and strategic element in reaching this goal. Therefore, Cisbio Bioassays has decided to develop a Quality Management System, by optimizing customer relationships and by implementing a management approach adapted to the needs of an international company.
The constant updating of our procedures in conformity with the requirements of international regulations also contributes to the reinforcement of an on-going improvement approach.
Cisbio Bioassays personnel can be proud of their long experience in the use of quality references, their contribution to the implementation of the Quality Management System and the reaching of these objectives.
All In Vitro Diagnostic medical devices manufactured by Cisbio Bioassays (except F-INFL-ELISA and S-INFL-ELISA) and distributed in the European Community carry the CE label, which guarantees that they are in conformity with the strict terms of the European Directive 98/79/CE concerning in vitro diagnostic medical devices.
The products in Appendix II list B (PSA and free PSA) have been certified by LNE/G-MED, notified body, in conformity with the regulatory obligations.