Certificates

One of the proofs of the quality our products are the certificates we have acquired to date.  In  1995, having fulfilled all the conditions of the German certification company, RWTÜV Essen, we obtained a certificate under the ISO 9001 Standards, as the first Czech manufacturer of implants and tools for orthopedics and traumatology to acquire this certificate.  In 1999, we added a special certificate of conformity with EN 46001 Standards from a Czech company, CERT-ACO, for production of medical aids.  In 2003, we obtained yet another certificate of conformity with the new ISO 13405:2003 Standards for the quality system of manufacturers of medical aids from a Norwegian certification company DNV (Det Norske Veritas).  The latter certificate substitutes fully the preceding certificates. 

Since 1998, we have fulfilled the conditions for using the mark of CE conformity under the European Directive 93/42/EEC for the entire assortment of our products.  This license is granted to implants by a notified entity, NB 0434-DNV (Det Norske Veritas).  Furthermore, we have a certificate of conformity for Russia.  

The above documents testify to our company's conformity to legislative requirements for marketing medical aids in the EU markets.