Excellence Certifiée : Notre Engagement envers la Qualité

Certificates

Quality

An internationale certification

Steriservices benefits from internationally renowned certifications. Our commitment to the quality and safety of the products we handle is recognized by leading certification bodies such as GMED (Groupe de Contrôle des Dispositifs Médicaux) and the Japanese Ministry of Health.

We see these certifications as recognition of our expertise, dedication and commitment to excellence in the field of medical device sterilization. They testify to our commitment to the safety of patients, healthcare professionals and the partners with whom we collaborate.

Steriservices complies with

NF EN ISO 13485 requirements.

More details :

This certificate covers the following activities :

Validation ans routine control of sterilization process by ethylene oxide according to standard NF EN ISO 11135 : 2014.

Validation and routine control of sterilization process by moist heat according to standard NF EN ISO 17665-1 : 2006.

Ce certificat couvre les activités suivantes :

Manufacturing of peelable pouches, or blisters by thermoforming, packaging, manufacturing of solution in bottles and cleaning of medical devices as subcontractor. Sterilization by ethylene oxide and moist heat, storage and distribution for medical device industry.

Contract manufacturing, packaging and sterilization of injection kits

Japanese certificate awarded by the Minister of Health, Labour and Social Affairs:

Foreign certified manufacturer of medical devices in accordance with article 23-2-4 of the Pharmaceutical and Medical Devices Act.

We are registered with the Federal Drug Administration in the United States, demonstrating our commitment to the quality and safety of our services.

Contact us now to start your project !

+33 (0)2 32 43 00 19