Setting sensitivity to yeast-like fungi

26.08.2021

Regulatory requirements for medical devices in laboratory practice

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, […]

The Pharmacy weekly has published a review article about the seminar “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”

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 […]

EU certificate for medical devices: the thorny path of recognition

ThePharmaMedia The first independent pharmaceutical business portal. The text of the article is available only in Ukrainian