Yuria-pharm LLC

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.

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.

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.

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.