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Quality and certificates

Cryo Equipment: EC Certificate of Conformity

EC Certificate of Conformity

This certificate shows that Cryomed’s equipment is compliant with health, safety, and environmental protection standards approved by the European Union. In our case, this is not self-certification, but a certificate issued by a notified body based on the results of testing. Our certificate also lists the applicable EC directives.

The Certificate of Conformity is accompanied by mandatory CE marking.

Cryo Equipment: Medical Device Certification ISO 13485:2016

Medical Device Certification ISO 13485:2016

ISO 13485:2016 certification demonstrates that Cryomed’s quality management system is able to make sure that our medical devices and related services consistently meet customer and applicable regulatory requirements. Currently, Cryomed is the only manufacturer of cryogenic devices that complies with the latest version of ISO issued in 2016.

We are proud that our certificate was issued by TÜV Rheinland, one of the most reputable certifying bodies in the world.

Cryo Equipment: Medical Device Certification ISO 13485:2016

Medical Devices Directive 93/42/EEC

This certificate confirms Cryomed’s meeting the essential requirements of European Union Directive 93/42/EEC regarding medical devices, often abbreviated to the Medical Device Directive. The certification covers the devices themselves, including their materials, as well as Cryomed’s quality management system.

As an additional benefit, medical devices with a CE mark have higher chances of faster approval beyond the European Union, if required by a specific country.

Cryomed passed regulatory review and received certification from one of the most reputable bodies in the area, TÜV Rheinland.