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On May 19, a webinar was held on the topic: “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”, the speakers of which were Viktoriia Shevchenko, Head of the Conformity Assessment Department of UNI-CERT LLC and Yana Sydiakina, Leading Specialist of the Assessment Division of UNI-CERT LLC.
The seminar showed the great relevance of carrying out conformity assessment of medical devices by recognizing certificates issued by notified bodies of the European Union for the period of martial law.
The Pharmacy Apteka published a review article about this seminar.
The full text in Ukrainian can be found here >>> https://www.apteka.ua/article/636039
PROGRAM Classification: medical device for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration Conformity assessment performed by conformity assessment body: choosing the best procedure for your business application and documentation step-by-step description of the conformity assessment procedure through an audit of the manufacturing facilities special procedure for III class devices, […]
Read moreThe program of the event is available only on Ukrainian or Russian
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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