Certificates

EUROGINE believes that quality is the basis for the success of a company and for this reason it has developed a Quality Management System based on the ISO 13485, which can satisfy the needs of customers, meet with applicable legal requirements and set goals for a continuous improvement.

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.

The Quality Management System is certified through regular audits by the accredited Notified Body “Centro Nacional de Certificación de Productos Sanitarios” (CNCps).

Furthermore, in compliance with the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR), all IUDs manufactured by EUROGINE are CE marked.

Copper-bearing intrauterine contraceptive devices are classified as Class III, which is the class of greater regulatory requirements under the European Regulation, that involves a strict and rigorous control of production processes thereof.

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).

Likewise, EUROGINE holds a Prior Health License to operate granted by the “Agencia Española de Medicamentos y Productos Sanitarios” (AEMPS).