Nous assurons le nettoyage, l’assemblage et l’emballage de vos dispositifs médicaux en environnement propre, ainsi que leur traçabilité.
We handle medical devices following strict standards to ensure safety and reliability.
Our processes cover all key stages of device packaging, adapting to different implants and surgical instruments while respecting materials, designs, and regulatory requirements.
Devices are cleaned and disinfected following validated procedures to ensure compliance with current technical and regulatory standards. The cleaning protocols adhere to ISO 19227 and ASTM standards, and advanced supercritical CO₂ technology is used to maintain the highest level of hygiene.
Packaging is performed in ISO 7 cleanroom facilities using ISO 11607 certified equipment, which ensures that devices remain protected during storage and transport. Standard pouches and blister packs are available, along with custom blister designs and the SoBliss® packaging system. Tailor-made accessories, such as SoTab®, SoEasy®, and SoKlean® holders or clamshells, are also provided as needed.
Assembly and kit preparation are carried out under controlled cleanroom conditions according to established manufacturing practices. Operations include ultrasonic and adhesive-based assembly, mechanical assembly such as screwing and component placement, and other methods as required.
Each device is tracked throughout the production process, from cleanroom handling to sterilization. This includes label printing (standard or customized), QR code and data matrix tracking, custom box labeling, and management of GAMMA or ETO sterilization.
