PROGRAM
Devices at the border of definitions:
Conformity assessment through self-declaration.
Conformity assessment performed by conformity assessment body:
Conformity assessment of medical devices through the recognition of EU certificates:
Declaration of conformity.
Conducting of surveillance audits for issued certificates.
Nikolay Matlaev, The lead auditor on certification of quality management systems and conformity assessment with technical regulations of the Ukrainian Scientific Institute of Certification
Journal “Laboratory” No. 04/2024 The text of the article is available only in Ukrainian
Read moreThe program of the event is available only on Ukrainian or Russian
Read morePROGRAM Temporary changes in the rules of import of medical devices and personal protective equipment needed to prevent the COVID-19 Conformity assessment procedures: self-declaration or assessment with the involvement of a designated body Requirements for accompanying documentation: labeling, instructions for use, declaration of conformity Application of the requirements of the Law of Ukraine “On ensuring […]
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