Quality & Certifications

Certified systems Measured accuracy

German Medical Technology GMT holds certificates ISO 9001:2015 and ISO 13485:2016. All medical products are manufactured in accordance with the European Medical Device Regulation (MDR) 2017/745. Dimensional and surface control is performed in our metrology laboratory using coordinate measuring machines (CMM) and optical 3D scanners.

Product traceability

How every batch is tracked (material → process → control → shipment)

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Material under control

Incoming control and identification of raw materials with assignment of a unique batch number.

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Technology trail

Recording of all processing parameters, equipment and operations performed at every stage.

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Proof of accuracy

Measurement results and quality control linked to a specific batch.

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Complete history until shipment

Data archiving and formation of a complete document package before dispatch to the client.

Certified standards

ISO 9001:2015

Quality management system

ISO 13485:2016

Medical device quality management system

MDR (EU) 2017/745

Compliance with the medical device regulation

Principles of the quality system

Systemic approach

Quality is ensured not by individual checks but by a holistic management system that covers all stages — from receipt of raw materials to shipment of finished products.

Metrological reliability

Measurements are performed on calibrated equipment under conditions that guarantee repeatable and reproducible results. Every measurement has confirmed metrological traceability.

Traceability at all levels

Every batch has a complete history: material, equipment, operator, process parameters, control results. This allows the production course to be restored at any moment.

Process validation and verification

Critical processes undergo validation. We confirm not only the result’s compliance but also the stability of the process itself.

Compliance with regulatory requirements

The quality system is built taking into account the requirements of ISO 13485 and MDR. This is not a formality but a working tool that ensures product compliance with medical standards.

Continuous improvement

The quality system is not static. We analyze deviations, complaints and audit results in order to systematically raise the level of control and reduce process variability.