Medical Components

Yes. Injection moulding for medical components takes place in production cells in a classified ISO Class 8 cleanroom environment per ISO 14644-1:2015, operating under the ISO 13485 QMS. Downstream assembly, inspection, printing, and packaging move into two validated ISO Class 8 cleanrooms. Routine internal particle-count monitoring (0.5 / 1.0 / 5.0 µm bands) is complemented by annual external verification by a specialist; the 2018 site expansion added 200 m² of additional ISO Class 8 cleanroom capacity.

Yes. Assembly, inspection, printing and packaging of medical components are all carried out in Carmo’s validated ISO Class 8 cleanrooms, under the ISO 13485 QMS. Component-level traceability documentation accompanies cleanroom-produced parts (batch records, in-process controls, material-lot traceability) in a documentation set sized for medical-OEM supplier qualification and customer audit.

A deliberate choice that serves your regulatory file. Danish in-house production gives full control of quality, traceability, and documentation: the audit-ready chain medical-device OEMs depend on, with no offshore links to qualify. Because production is highly automated, the cost gap to a lower-cost region is modest, so you get competitive pricing without trading away control. That control also supports your sustainability reporting: component-level CO₂ data for scope 3, under an SBTi commitment to halve scope 1 and 2 emissions by 2030.

Yes. Beyond the standard catalogue, Carmo develops OEM-specific variants and fully custom-designed components from concept through volume. The integrated design, tooling, moulding, and cleanroom-assembly teams handle the full lifecycle without supplier handovers, which simplifies your regulated documentation. New designs typically start with Carmo Print Moulding for iteration in production material (see /en/services/rapid-prototyping/) and transition into definitive tooling for volume.

Yes. Carmo offers rapid prototyping of medical plastic components from Denmark. Carmo Print Moulding, Carmo’s own hybrid of 3D-printed mould tooling and injection moulding, delivers functional prototypes in the real production material in days, not weeks. Because prototypes are moulded rather than printed, fit, function, and HF-weldability can be tested on parts that behave like production components, before any investment in definitive tooling. Prototyping runs outside the certified ISO 13485 scope on case-by-case engineering documentation; from validation builds onward, the same engineering team carries the design into regulated volume production. See rapid prototyping services.

Your project doesn’t change hands between prototype and volume. The same engineering team carries your project from Carmo Print Moulding iteration through validation builds and into regulated volume production. Carmo Print Moulding sits outside the certified ISO 13485 scope (rapid-iteration prototyping runs on case-by-case engineering documentation); validation builds and volume production engage the certified ISO 13485 quality system. Your supplier qualification, audit trail, and documentation extend rather than restart at that boundary, removing the cost of re-qualification, audit, and renegotiation that customers face when moving between separate prototype and production suppliers.

Yes. Carmo’s certified ISO 13485 scope reads verbatim: “Design, development, manufacture and assembly of injection molded plastic components.“ Design and development are inside that certified scope, not adjacent to it. Supplier-qualification documents, on-site audits, and questionnaires are part of the routine engagement model from the design phase onward, drawn from the same procedures and records as volume production. The QMS has been continuously certified since 2013.

A family of two one-piece 2K-moulded drain valves for medical bags, built on Carmo’s granted Cross Valve and Turnvalve patents, engineered to replace multi-component assembled valves. One piece instead of an assembly: fewer parts, fewer failure points, lower component cost, less material per device, lower CO₂ footprint. Unveiled at COMPAMED: pilot engagements with selected medical-bag OEMs scoped on request.

With Carmo you get a supplier who is there as long as your device is in the market. Twenty- to thirty-year relationships are common; medical OEMs have run the same Carmo components on the same medical device for the regulated life of the device, including through validation cycles, regulatory pathway updates, and material transitions. Privately held and Danish-owned since 1941: the relationship is engineered to outlast your validation cycle, and the structural continuity is the reason it can.

Yes, and the hybrid model is what gives Carmo lifecycle insight no pure contract manufacturer can build. Because Carmo also develops and lives with its own component portfolio over decades, the team has first-hand experience of the full lifecycle cost of design choices: material changes (REACH, RoHS, DEHP phase-outs), copy tooling at end-of-life, re-validation triggers, regulatory pathway updates, the practical realities of sustaining a medical-device component over its registered life. That’s depth a pure contract manufacturer can’t offer, and it all comes with the partnership. Customer projects run under the same QMS, the same engineering team, the same priority model; Carmo’s own product work sits in the same queue, not ahead of it.

A component-level CO₂ calculator runs directly in Carmo’s ERP and produces per-component emissions data you can include in your scope 3 reporting. It makes per-component carbon intensity visible at the granularity OEMs need to support their own sustainability disclosures: actual numbers for your specific component runs, not segment-level averages. Carmo is among the first Danish plastics SMEs committed to the Science Based Targets initiative (SBTi certificate 40001785), targeting a 50% reduction in scope 1 and 2 emissions by 2030 aligned with the Paris Agreement 1.5°C target.

Engage at the concept or design stage to get the full benefit of design-for-manufacturability, material selection, and rapid prototyping in production material before tooling investments are committed. Contact [email protected] or visit carmo.dk; a brief one-way NDA covers the scoping discussion (turnaround in days, not weeks), with a mutual, project-specific agreement settled before development work begins. If your project is on a tight timeline and your component need matches Carmo’s standard catalogue (HF-weldable eyelets, valves, threaded nozzles, filler flanges, snap grommets, drainage fittings), the fastest path is to start from the catalogue: proven designs available from stock, produced under the same ISO 13485 QMS as custom work.