Yuria-pharm LLC

• Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico
  ItalyContact the authority →

Devices placed in 2 countries

• Italy8
• Latvia1

No certificates registered for this manufacturer.

6 contacts identified

• PO
  PAVLENKO Olena

  PRRC
  View profile →
• STRIUCHENKO (PROSIANYK) Alina
  Communicates with conformity assessment bodies/ notified bodies: submission of applications, approval of dates, audit format, signing of certification agreement and related documents · Manages technical files for medical devices – development, updating, storage · Manages Declarations of Conformity for medical devices - development of declarations, making changes to declarations; · Provides information about the functioning of relevant quality system processes to senior management.
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• TRUNOVA Nataliia
  Authorize release of medical device batches and confirm compliance with regulatory and technical requirements; approve use of materials and QMS documentation; participate in audits, validations, inspections, and process changes; supervise nonconformity, complaint, withdrawal, and CAPA activities; monitor deviations and manufacturing processes; issue corrective instructions; and report QMS performance to top management.
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• PAVLENKO Olena
  Authorizes release of medical device batches and confirms compliance with ISO 13485 and regulatory requirements; ensures validated manufacturing and testing processes, deviation control, CAPA effectiveness, and batch dossier assessment; approves materials, suppliers, validations, and documentation; participates in audits and inspections; coordinates complaints and recalls; oversees process changes and quality control; and reports QMS performance to top management.
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• ZELENKO Valentyna
  Authorizes release of imported medical device batches at Pharmaceutical Warehouse No. 8; performs incoming control by verifying documentation, conformity marks, customs data, labeling, packaging integrity, and product appearance; confirms availability of quality and conformity certificates; authorizes sale after positive inspection; monitors storage conditions; and reports on quality system performance to senior management.
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• VORONIN Pavlo
  Develops and implements post-market surveillance (PMS) plans for medical devices; collects and analyzes PMS and market feedback data; monitors regulatory changes; prepares PMS reports for management and authorities; supports complaint, incident, and serious incident investigations; prepares vigilance and trend reports, including field CAPA documentation; maintains market feedback systems; and reports PMS system performance to senior management.
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• Diaco Biofarmaceutici srl — represents — Yuria-pharm LLC
• PAVLENKO Olena — Yuria-pharm LLC