Cryomed is proud to share our latest news – we’ve became 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.
For your reference:
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Annex II: Full Quality Assurance System – This conformity assessment includes a review of the manufacturer’s entire quality management system that includes design, manufacturing, and final inspection.