Certificates

Eurogine believes that quality is the basis for the success of a company and for this reason it has developed a management system based on the 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 Regulation (EU) 2017/745 of the european parliament and of the council on medical devices (MDR) and Royal Decree 192/2023, all products manufactured by EUROGINE are CE marked and holds a Prior Health License to Operate granted by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). In the portfolio of products manufactured by EUROGINE you can find Copper-bearing 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 13485: 2018. Requirements for Medical Devices. This certificate is issued by an accredited notified body, which in the case of EUROGINE is the Centro Nacional de Certificación de Productos Sanitarios (CNCPS). The requirement to comply with a Quality management system aligned with the MDR regulation is mandatory for those companies that manufacture Class III medical devices (according to Article 10.9 and Annex IX of the MDR Regulation). ISO 13485 is based on the structure of ISO 9001 but with some important added requirements such as product traceability (forward and backward history of the product life) and the Risk Management.