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Production · Russia

Medical Device Contract Manufacturing in Russia

Three production models: contract assembly, sourcing and launch of your own line, placement at a partner facility with ISO 13485.

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Production Models

Three Scenarios

1

Contract Assembly

Production at qualified partner facilities under our quality management. Fast start, minimal investment.

2

Line Setup

Equipment sourcing, supplier selection, line commissioning. For serial production from 500+ units/year (for complex, highly technical devices this threshold can be lower — negotiated individually).

3

Partner Facility

Production placement with ready ISO 13485 QMS infrastructure.

QMS

QMS & ISO 13485

Quality management system build for MD production and regulatory inspection.

QC

Quality Control

Incoming inspection, in-process control, final testing, batch traceability.

PKG

Packaging & Labelling

Primary and secondary packaging, GOST labelling, sterilization preparation.

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Describe your device and task — we will respond within one business day.

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