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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 morePROGRAM Devices at the border of definitions: medical devices supplied with the medicinal product; medical devices as a means of drug delivery; devices, an integral part of which is a medicinal product; devices for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration. Conformity assessment performed by conformity assessment body: choosing […]
Read moreQuality management // № 5 (41), May 2021 The text of the article is available only in Ukrainian
Read moreOn May 14, the 10th anniversary Ukrainian forum of medical device market operators took place, which traditionally provides manufacturers, suppliers, distributors, importers of medical devices with a platform for communication and exchange of valuable business experience. Ukrainian Scientific Institute of Certification was a partner of this event. In addition, Anna Telpiakova, First Deputy Director of […]
Read moreOnce again, the Ukrainian Scientific Institute of Certification has extended the accreditation scope of its Testing Laboratory UNI-CERT LLC, and this time by 23 standards and 127 test indicators in the field of Personal Protective Equipment (PPE). According to the accreditation certificate No. 201394 and number of additions to the accreditation scope, the Testing Laboratory […]
Read moreQuality management // № 4 (40), April 2021 The text of the article is available only in Ukrainian
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