Quality Management System Implementation for a Medical Device Manufacturer

Victoria Shalaeva, an INCM Global expert, implemented a Quality Management System (QMS) in compliance with ISO 13485 for a Russian manufacturer of electrical measuring equipment for medical use. The company has a full in-house production cycle, which required ensuring compliance of all processes with international quality requirements.

The project included implementation of the QMS documentation framework, as well as preparation and support during the initial production inspection conducted by the All-Russian Scientific Research and Testing Institute of Medical Technology (VNIIMT) under the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

The inspection was completed successfully and without remarks, and the manufacturer received a positive audit report confirming compliance with ISO 13485 requirements.

As a result, the company now operates with a certified quality management system that ensures regulatory compliance, strengthens production reliability, and supports its readiness for future international certification and export.

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