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ISO 13485

Nowadays inculcating and maintaining the Quality Management System is simply a must, especially for companies which plan to continue their stable development. In such a delicate matter as a person's health, it is that much more important. There is no room for compromise.

The market of medical products is very sensitive and fragile. Any uncontrolled action could lead to disastrous effects. A certified Quality Management System makes our customers feel secure - we become a more credible and qualified producer, that fully controls the provided products.

In the case of medical products, it is important to conform to requirements of the standard that describe the System: EN ISO 13485 - Medical devices. Quality management systems. Requirements for regulatory purposes

We have decided to inculcate ISO in the beginning of year 2003. It turned out that developing and inculcating the Quality Management System is not so tough - especially for a company that had a deep concern for quality from the very beginning.

Since 1st September 2003 we have a certified Quality Management System, which conforms to the standard EN ISO 13485.
We were certified by ICR Polska Sp. z o.o.

The certification covered all major company processes, i.e. design, production, distribution and technical support (service) of the electronic medical devices.

EC certificates

All our devices conform the requirements of EU Medical Direcive and the CE certificate was issued.
We were certified by TUV Rheinland


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Last modified on: 05-08-2020
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