Medical device or medicinal product?

26.10.2021

UNI-CERT LLC has signed an agreement with the Turkish laboratory Ekoteks Laboratuvar ve Gözetim Hizmetleri

Dear colleagues and partners! We are pleased to announce that UNI-CERT LLC has signed an agreement with the Turkish laboratory Ekoteks Laboratuvar ve Gözetim Hizmetleri. Ekoteks Laboratory is accredited according to the standart of ISO/IEC 17025 with the number of AB-0583-T by TURKAK (Turkish Accreditation Agency), an independent certification body which is a member of […]

Communication and interaction with State Service of Ukraine on Medicines and Drugs Control and conformity assessment bodies

The program of the event is available only on Ukrainian

Stand-alone software as a medical device: Features of its classification and conformity assessment

Journal “Standardization, certification, quality” № 4 (122)/2020 Over the past decades, the frequency of using software in various areas of human life has increased significantly. In particular, this product has taken an important place in the medical industry. For example, as an integral part of a medical device (software incorporated in medical devices or pacemaker […]