As a company accredited by NAH, we certify quality management systems.

Our company is a certification body accredited by NAH, so we are authorised to perform certification according to standard ISO 13485:2016.

Information on the certification procedure:

Our certification procedure of MSZ EN ISO 13485:2016 is shown in the following illustration:

REQUEST

Inquiries are to be sent to our request@cecertiso.hu address!

Manufacture of medical devices is a special industrial branch since these devices and equipment are used in medicine, so the safety of them has enhanced importance in addition to the intended use.

Standard ISO 13485:2016 rules the procedures of manufacture of medical devices from the design to the application. It guarantees that the product fulfils the regulatory requirements of Hungary and the European Union.

Standard ISO 13485:2016 has been prepared for such organisations that, for using the CE mark on their products, shall conform one or more “New Approach” European directives on medical devices.

A certified ISO 13485 quality management system provides the following added values:

  • During the validity of the certificate, an external and independent certification organization proves that your procedures fulfil the requirements of the standard.

  • You’re entitled to use our certification mark

  • You can get a priority in public procurements

A list on withdrawn, suspended and forged certificates can be found under the Certificate information menu

The list of our certified clients is available upon request. Please submit your requests in writing to our addresses.