As a critical subcontractor in the field of medical devices, Cisteo MEDICAL has chosen from the first years of its creation on to certify its quality management system according to ISO 13485. Today, this goes even further by declaring our quality management system compliant with 21 CFR Part 820 as a "Contract Manufacturer" with the FDA (Food and Drug Administration) registration.
This decision was made for two reasons:
- First, increasing the reliability and efficiency of design, development, manufacturing services and thus ensuring the continuous improvement of Cisteo MEDICAL;
- Second, allowing our current customers or new customers (European and American) to market their products in the United States.
Quality management system certification covers activities supporting design and development of medical devices as well as manufacturing from purchase of components/raw materials through manufacturing, assembly and cleaning, to final packaging (with sterile barrier system if applicable).
The company's support teams are also concerned with quality requirements by ensuring the implementation of good documentary practices, traceability, identification, equipment management, management of manufacturing processes as well as continuous staff training.
To conclude, Cisteo MEDICAL is now authorized to offer services and to manufacture medical devices that can be delivered on European and American countries.