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Since the Technical Regulations entered into force, discussions on the possibility of simplifying conformity assessment procedures, especially for medical devices of high-risk classes have been underway. Recently, we have had positive and relevant news regarding the recognition procedures in Ukraine for certificates of conformity issued by some notified bodies, accredited in the EU. To put it simply – the recognition of EU certificates for medical devices.
PROGRAM The importance of quality control of medical products for business Classification of medical products SI units Marking. Meaning of symbols. New symbols of 2022. Instructions for medical products Accompanying documents. Certificates of conformity. Declaration of conformity. Methods of checking the validity of certificates
Read moreThe Ukrainian Scientific Institute of Certification invites you to take part in the 12th Ukrainian Forum of Medical Devices Market Operators®. In this difficult period for our country, more than ever, it is necessary to be aware of the latest key changes in the functioning of the medical device market. Therefore, the Ukrainian Forum of […]
Read moreDear 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 […]
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