As a CMO (Contract Manufacturing Organisation) or CDMO (Contract Development Manufacturing Organisation), Cisteo MEDICAL has a 250 m² cleanroom environment for the manufacture and assembly of highly technical medical devices.
To achieve this, we master key processes such as medical-grade silicone injection, nitinol shaping, blister packaging and laser welding in cleanrooms (ISO 5 and ISO 7). The latter also incorporate innovative processes that can be mobilized for customized subcontracting.
Our team helps you to make the transition from R&D to manufacturing. We challenge design choices to ensure that the device is manufacturable, but also respects set cost targets.
The design for manufacturing phase enables us to integrate manufacturing constraints as design input data.
Begun as early as possible, this phase enables the design to evolve before a design freeze, which can be restrictive in terms of cost.
At Cisteo MEDICAL, we support you in the crucial phase of design verification. Our services include drafting protocols, carrying out tests and producing detailed reports, as well as designing and manufacturing customized test benches. Then, during design validation, we manufacture devices specifically for this phase, ensuring complete production documentation, rigorous supplier qualification, process validation and control of the production environment.
Cisteo MEDICAL carries out small-scale production, and then launches production to guarantee the delivery of larger volumes, in particular by setting up suitable, repeatable processes. This stage involves research into processes compatible with mass production, flow organization and the design and production of tooling.
We can also integrate existing production processes as part of dual sourcing or when switching to an ISO13485 subcontractor.
Following the drafting of the customer requirements matrix and the process risk analysis, we implement process validation by test batches and IQ/OQ/PQ, as well as the manufacturing documentation (DMR) (selection and qualification of suppliers, nomenclature, manufacturing and inspection instructions, tooling and equipment maintenance plan).
As a global partner to medtech start-ups and manufacturers of innovative medical devices, Cisteo MEDICAL implements a wide range of processes for :
In addition to those detailed below, and to better meet your specific needs and requirements, we are available to set up, monitor and validate new processes.
Whether it's double sourcing or a new device, we're at your disposal to work with you on the production of your medical device.
