The EC Certificate of Conformity
The EC Certificate of Conformity is an important document for production, located in the European Economic Area market.
The Certificate of Conformity is a legal document, which confirms the conformity of the product to EU standards.
Granting the certificate is accompanied with getting the CE mark, which is mandatory.
CE mark (an abbreviation of fr. ConformitéEuropéenne – European Conformity) is found on a product and confirms, that a product complies with EU directives and EU standards, and also indicates that the conformity assessment procedure has been carried out accordingly.
CE marking indicates, that a product is safe for the health of its consumers, and also that is not harmful to the environment. The CE mark is the only mark in the EU countries, which confirms the conformity of the production to EU standards of human safety, property and environment.
The receipt of a Certificate of Conformity is not mandatory, but it makes a product more competitive, demonstrates attention to quality and gives confidence about quality for those, who use it. To sell a product like this is a pleasure for distributors. The final consumer is also satisfied.
The Certificate is granted for 3 years, which also means that experts have reviewed the production and accept it is excellent and solid.
The Certificate of Conformity, received by Cryomed s.r.o. for the newest model of cryosauna, Cryomed PRO is an acknowledgment of our achievements and a confirmation of our experience.
Cryomed PRO complies with:
ЕС Machinery Directive
Electromagnetic Compatibility (EMC) Directive
Certificate EN ISO 13485:2012
One more achievement of Cryomed s.r.o. !
The series of ISO standards is used during the process of creation and improving of a Quality management system. A certificate like this shows that everything in the firm works in coordination and to ensure the client is satisfied by the quality, service and management.
The ISO Certificate confirms the solid reputation of the firm on the market.
The Cryomed s.r.o. company has received certificate ISO 13485:2012 (ISO 13485:2003 + Cor 1 :2009)
This confirms the conformity of producer’s quality management system for medical devices to international standards.
Standard 13485 concerns medical and related services in a broad sense. It contains the requirements for the storage buildings; health of employees, equipment and areas; and the methods of recalling the production in case of accidents.
ISO 13485:2003 is also about:
- Focusing on the customer
- Systematic approach to management
- Leadership of a chief
- Involvement of people
- Mutually beneficial relationships with suppliers
- Decision-making, based on facts
- Continuous improvement
The granting of this certificate happens after expert’s checking of the production. The experts have verified the production of Cryomed s.r.o. and approved it is qualitative and solid.
Thereby, the production of Cryomed s.r.o. is a certificated medical device, which the firm has the right to produce, sell and distribute.
If you want to buy a cryosauna, you should ask if the producer has international quality certification.
If you would like to try the cryoprocedures you must be careful about to whom you trust your body and health.
Cooperation with Cryomed s.r.o. is a guarantee of quality and service.
EC Certificate – Full Quality Assurance System No. 18 0491 QS/NB
Our new device – Cryomed Pro M – has been certified as meeting the requirements of Directive 93/42/EEC on medical devices, Annex II excluding (4) and is now officially a Medical Cryotherapy Device class 2B.
This means that Cryomed Pro M is now available to the medical industry (hospitals, private clinics, etc.) in some EU countries.