13th Ukrainian Forum of Medical Devices Market Operators®

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15.04.2022

Conformity assessment requirements for subcontracting manufacture (OBL-OEM). Technical file structure.

The program of the event is available only on Ukrainian or Russian

24.09.2020

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 […]

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08.06.2022

UNI-CERT received accreditation for DSTU EN ISO 22716:2015

The Ukrainian Scientific Institute of Certification became the FIRST conformity assessment body in Ukraine, accredited to carry out activities in a new line of business: DSTU EN ISO 22716:2015 Cosmetics. Good Manufacturing Practice (GMP). Guidelines on Good Manufacturing Practices (EN ISO 22716:2007, IDT) and EN ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP) – Guidelines […]

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