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PROGRAM
Nomenclature of medical devices in the “product portfolio” of pharmaceutical companies:
Requirements of the international standard ISO 13485: 2018 Medical devices – Quality management systems – Requirements for regulatory purposes.
Requirements of the national standard DSTU EN ISO 13485: 2018 Medical devices. Quality management system. Regulatory requirements
The procedure for conducting audits of the QMS of companies producing medical devices.
Nikolay Matlaev, Lead Auditor of the Conformity Assessment Department of the Ukrainian Scientific Institute of Certification
The text is available only in Ukrainian
Read moreThe program of the event is available only on Ukrainian
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 […]
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