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
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