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ISO 13485

We have implemented and keeping the quality management system complies with the requires of the EN ISO 13485:2016 standard. Conformity of the quality management system is confirmed with certificate granted by TÜV Rheinland Polska Sp. z o.o. – which concerns design and development, manufacturing, distribution and service of medical devices used for rehabilitation of disabled people.

Under the quality management system:

The implemented quality management system for medical devices, in addition to the transparency of internal processes, ensures compliance with international law, enhances the safety of the offered equipment and affects the efficiency of the entire company.

Manufactured medical devices meet the requirements of the applicable regulations, including Council Directive 93/42 /EEC of 14 June 1993 concerning medical devices.

Any medical device has an EC declaration of conformity and a CE-labeled plate. Medical devices are reported and registered in the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

We undertake to comply with the requirements of the applicable regulations and to continuously improve the effectiveness of the implemented quality management system.