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Plastic injection moulding for medical devices
Developing a medical device and looking for a subcontractor who can guarantee traceability, regulatory compliance and consistent production?
Cemiplast designs and manufactures your moulded plastic parts in Saint-Imier, Switzerland. ISO 13485 certified since 2016, it carries out plastic injection moulding for medical devices in an ISO 7 cleanroom.
Why choosing a plastic injection moulding subcontractor for medical devices is critical
A medical device makes its manufacturer responsible for the entire production chain, including its subcontractors. The choice of injection moulding partner therefore determines compliance with the European MDR and the reproducibility of parts from one batch to the next. It also determines the ability to document every step in the event of an audit.
That is why an ISO 13485 certified subcontractor with qualified cleanrooms reduces this risk from the part design stage, rather than discovering it during production.
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injection moulding machines
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ISO 7 cleanrooms
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-100T
tonnage
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ISO 13485 certified
Plastic injection moulding manufacturer for medical devices
As an industrial subcontractor for medical devices, Cemiplast operates 7 injection moulding machines, 3 of them used exclusively in the cleanroom, with clamping forces from 25 to 100 tonnes.
The company carries out plastic injection moulding of parts for medical devices, from design through to series production. It also pays constant attention to the traceability and process qualification required by the medical sector.
Materials used in plastic injection moulding for medical devices
PE, PP, PPS, PSU, PEI, POM, PEEK and ABS, selected according to the biocompatibility and mechanical requirements of the device.
Plastic injection moulding processes for medical devices
Micro injection moulding, insert overmoulding and two-component moulding, suited to the precision and miniaturisation specific to medical parts.
How we work on your medical devices
They trust us
Frequently asked questions about plastic injection moulding for medical devices
Yes. Cemiplast works as a plastic injection moulding subcontractor for medical device manufacturers, from part design to series production, in Switzerland.
Yes, Cemiplast has two certified ISO 7 cleanrooms dedicated to medical production that requires a controlled environment. The ISO 7 standard sets the maximum concentration of airborne particles allowed in a production environment.
Cemiplast has been ISO 13485 certified since 2016, the reference standard for quality management systems of medical device manufacturers.
Yes. Cemiplast’s multidisciplinary team integrates the requirements of the MDR and the ISO 13485 standard from the part design stage.
Yes. Cemiplast’s ISO 7 cleanrooms combine plastic injection moulding, assembly, inspection and packaging of parts for medical devices.