Certificates

Eurogine believes that quality is the base for the success of a company and for this reason it has developed a management system based on the UNE-EN ISO 9001 and UNE-EN ISO 13485, which can satisfy the needs of customers, meet with applicable legal requirements and set goals for a continuous improvement.

The quality management system is certified through regular audits by accredited Notified Bodies. Also in compliance with the European Medical Device Directive 93/42/EEC and Royal Decree 1591-2009, all products manufactured by Eurogine are certified with the CE marking and hold a Health facility operating license granted by the Spanish Agency of Medicines and Medical devices. In the portfolio of products manufactured by Eurogine you can find Intrauterine Contraceptive Devices classified as Class III, which is the class of greater regulatory requirements under the European Directive and involve a strict and rigorous control of production processes thereof.

Quality management system - ISO 9001: 2015. This certificate is issued by BSI and it audits annually the management system and refers in particular to continuous improvement and customer satisfaction. It is renewed every 3 years.
 
Quality management system - ISO 13485: 2013. Requirements for Medical Devices. This certificate is issued by an accredited notified body, which in the case of Eurogine is the Spanish Agency for Medicines and Medical Devices (ON 0318). This certificate is required for obtaining those companies that have products Class III (according to Annex 2 of the European Directive). ISO 13485 is based on the structure of ISO 9001 but with some important added requirements such as product traceability (history forward and backward product life) and Risk Management.
 
 

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