ISO 13485 injection moulding subcontractor: certification covering processes and products
Looking for an ISO 13485 certified injection moulding subcontractor in French-speaking Switzerland?
Cemiplast has been ISO 13485 certified by SwissSafetyCenter since 2016, for its processes and products. The company also integrates MDR requirements from the design stage of parts intended for medical devices.
ISO 13485 injection moulding subcontractor: certification covering processes and products
Cemiplast’s ISO 13485 certification covers both manufacturing processes and delivered products. It ensures traceability and quality control across the entire chain, from design to delivery.
An ISO 13485 injection moulding subcontractor familiar with MDR requirements
Cemiplast’s multidisciplinary team integrates the regulatory requirements for manufacturing medical devices from the design stage. It thus limits the risk of non-conformity when moving to industrialisation.
Cemiplast’s regulatory compliance is based on five complementary strengths: a multidisciplinary team, a holistic approach from design to production and management of regulatory requirements for medical devices. Add to this ISO 13485 certification of processes and products, and expertise in cleanroom production.
ISO 13485 injection moulding subcontractor: how we work with you
They trust us
Medical device manufacturers choose Cemiplast for its ISO 13485 certification and its command of regulatory requirements.
Frequently asked questions: your ISO 13485 injection moulding subcontractor
Cemiplast, based in Saint-Imier in the Bernese Jura, has been ISO 13485 certified since 2016 for its processes and products. The company manufactures plastic parts for medical devices.
It covers both: Cemiplast’s ISO 13485 certification applies to manufacturing processes and to delivered products.
A multidisciplinary team, a holistic approach from design to production and management of regulatory requirements. Add to this ISO 13485 certification and expertise in cleanroom production.
Cemiplast has been ISO 13485 certified by SwissSafetyCenter since 2016.
Yes. Cemiplast has two ISO 7 cleanrooms in Saint-Imier, dedicated to medical production.