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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 Ministry of Health of Ukraine approved guidelines that are developed on the basis of relevant documents of the European Commission (MEDDEV) for an unambiguous interpretation of technical regulations regarding medical devices, medical devices for in vitro diagnostics and active implantable medical devices. The recommendations are not legally binding, but should be taken into account […]
Read moreThe program of the event is available only on Ukrainian
Read moreThe program of the event is available only on Ukrainian
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