Most of Carmo’s medical components can be supplied in a customised version, a specific colour, a raw-material recipe tuned to your sterilisation process, a modified geometry or an OEM-branded variant. When no catalogue part will do, the same engineering team develops the component from scratch and takes it into series production.
Two routes to the component you need
- A customised catalogue component. Start from a proven part, a connector, valve or flange, and change what your device needs: colour, material grade, sterilisation compatibility, packaging. It is the shortest route to series supply: the base part is already in production. See the medical components.
- Custom development. One engineering team takes the component from concept to ISO 13485-governed series production. Functional prototypes come in days, in the production material, with Carmo Print Moulding; the moulding process is validated (IQ/OQ/PQ) as the part moves into regulated volume. The whole arc is on Engineering & Injection Moulding.
What a medical project team can expect
Documentation and traceability run under Carmo’s ISO 13485 quality management system. Components are moulded in ISO Class 8 clean zones, then assembled, printed and packed in the validated cleanroom, and every delivery carries batch traceability. OEM variants are supplied to medical-device manufacturers worldwide.
Carmo A/S customises its medical components, colour, material, sterilisation, and develops new ones under the same ISO 13485 quality management system, in Espergærde, Denmark.
Tell us what the standard part needs to do differently: that is usually the fastest way to the right component. Contact sales.
Carmo A/S's quality management system is certified to ISO 13485:2016 Medical devices quality management system by Bureau Veritas (accredited by DANAK), certificate no. DK020611. Scope: Design, development, manufacture and assembly of injection molded plastic components. Valid: 2. September 2026 – 1. September 2029.
All Carmo plastic components are manufactured under the same QMS and procedures.