Cryomed Has Successfully Achieved Medical Certification

Cryomed became the only manufacturer of cryogenic devices in the world who complies with EN ISO 13485:2016 and received a certificate of conformity to the provisions of EC Certificate Directive 93/42/EEC Annex II.

Cryomed is proud to share our latest news – we’ve become the only manufacturer of cryogenic devices in the world who complies with EN ISO 13485:2016. In addition, we have received a certificate of conformity to the provisions of EC Directive 93/42/EEC Annex II. Moreover, the issuing body is one of the most reputable in the area, TÜV Rheinland.

As a manufacturer of medical devices, safety, quality, and efficiency are our priorities. That is why, despite the fact that regulatory requirements are becoming increasingly stringent throughout the product life cycle – including service life and delivery – we are always ready to comply with the strictest requirements.

In our factory, we have established and implemented a quality management system covering the manufacture, distribution, installation, and servicing of medical cryotherapy devices.

We firmly believe the trust of our clients and partners is worth all of the red tape every certification involves. And we believe we make life better to the extent that whole-body cryotherapy is able to make it.