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Quality and Safety

In accordance with our mission all activities are performed in compliance with ISO 9001 quality management standard. First time we got its certificate in 1998 from SGS Yarsley International Certification Services certification body.

In addition the production of in vivo pharmaceuticals is performed in compliance with requirements of GMP (Good Manufacturing Practice) which is regulated in Hungary by 44/2005 (X.19.) order of Health Ministry, and its realisation is regularly inspected by National Institute of Pharmacy.

All our products, as well as their production, storage and delivery meet the strictest security requirements. Prevention of radioactive pollution of the environment is guaranteed by a multilevel safety system.

All in vitro diagnostic products have CE compliance mark required by 8/2003 (III.13.) order of Ministry of Health, Social and Family affairs. Quality management system according to ISO13485 standard is certified for one in vitro diagnostic product, the certificate was issued by Institute for Medical Quality Improvement and Hospital Engineering in 2008. Implementation of this quality management system is now in process for all in vitro diagnostic products.

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