Certification

GeneProof a.s. is ČSN EN ISO 13485 and ČSN EN ISO 9001 certified.


GeneProof a.s. is ČSN EN ISO 13485:2012 and ČSN EN ISO 9001:2009 certified. Design, development, manufacturing and sales of in vitro diagnostic medical agents is the subject of the certification.

Company has been audited for CE IVD products by the NB1023 Notified Person according to the Council and European Parliament Directive 98/79/EC on in vitro diagnostic medical agents, requirements of which were adopted in the Czech Government Order No. 56/2015 Coll. establishing technical requirements for in vitro diagnostic medical agents.

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All GeneProof diagnostic kits are manufactured as in vitro medical devices complying with the requirements of the quality system defined in Council Directive No. 98/79/EC. 

GeneProof Hepatitis C Virus (HCV), GeneProof HIV type 1 (HIV-1) and GeneProof Hepatitis B Virus (HBV) diagnostic kits belong into List A according to this Directive.Procedure according to Annex No. 4 was used to assess the basic characteristics of the products in a specified way and their compliance was assessed by the Notified Body No. 1023 (Institute for Testing and Certification, Zlín, Czech Republic).

GeneProof Chlamydia trachomatis, GeneProof Chlamydia pneumoniae and GeneProof Cytomegalovirus (CMV) diagnostic kits belong into List B according to this Directive.Procedure according to Annex No. 4 was used to assess the basic characteristics of the products in a specified way and their compliance was assessed by the Notified Body No. 1023 (Institute for Testing and Certification, Zlín, Czech Republic).

Other diagnostic kits belong into other medical devices according to this Directive. Procedure according to Annex No. 3 was used to assess the basic characteristics of the products in a specified way.

 

GeneProof a.s. performs quality verification for all of its products. All products are subject to internal quality assessment. Kits are regularly tested by External Quality Assessment Panels QCMD and Instand e.V. as a part of the used technology continual improvement. For detailed information about the results of the individual programs see our website Quality Control

 

The Company takes care of recycling packaging materials from the purchased base materials and it participates in assuring returning and recycling of packaging waste organized by the EKO-KOM company under the identification number EK-F00041495. Disposal of potentially infectious waste is organized by an external supplier.