Cisteo MEDICAL of Besançon at COMPAMED 2022 in Düsseldorf -- COMPAMED Trade Fair
Manage stand orders
Select Option

Submit your contact details

Provide your contact details to the exhibitor. Optionally, you may also add a personal message.

Please log in

You must be logged in to send the contact request.

An error has occurred

Please check your internet connection or try again later.

Message has been sent

Your message to the exhibitor was sent successfully.

Company news

Date

Topic

28 Oct 2022

Cisteo MEDICAL is now FDA registered

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.

More Less

Please log in

You must be logged in to use matchmaking