Quality plays a fundamental role in Eurosirel’s philosophy and is compulsory in the Medical Device sector.

The company is constantly up-to-date and in line with the regulations that the European Community issues and that the member countries implement in their own laws.

Safeguarding the consumer’s health and controlling the production processes are the heart of the certifications that Eurosirel has obtained and maintains, in line with the provisions laid down by the European Community, that is:

• Process certifications
• Product certifications

Eurosirel has obtained 2 process certifications:

• ISO 9001: 2000 (general)
• EN ISO 13485:2003 (specific)

This means that the company keeps all its processes under close control: from the acceptance of the raw materials to the transformation process and the finished product packaging phase, so as to guarantee the conformance of the products to the requirements and needs of each individual customer.

Eurosirel has also been awarded numerous product certifications by the High Council of Health: these are required whenever the medical device concerned enters a higher class in accordance with the European Directive such as, for example, sterile or invasive devices or those containing substances with functions ancillary to the device itself.

Product Certifications

Notified body: ISTITUTO SUPERIORE DI SANITÁ - ORGANISMO NOTIFICATO N°0373 (THE HIGH COUNCIL OF HEALTH NOTIFIED BODY No. 0373)