Engineering & injection moulding

The people who design your part are the same people who run it at volume. Most of a component’s cost and risk are locked in early, before a tool is ever cut, and engineers who have spent years on the production floor design for what actually works at scale, not for what looks right on a drawing.

That one team stays with your project from concept through the prototype rounds, the validation builds under Carmo’s certified ISO 13485 quality system, and into regulated volume production. Because the work never changes hands, your supplier qualification, audit trail and documentation carry forward instead of restarting; your qualification holds as you scale up.

Yes, continuously since 2013. Carmo has run a certified quality management system since 1993, and certified to ISO 13485 since 2013:

Design and development sit inside that certified scope, not adjacent to it, so the engineering you engage at concept runs under the same QMS that governs your regulated volume production. Carmo is a component supplier; MDR legal-manufacturer responsibility rests with you as the OEM placing the finished device on the market.

Yes, for components. Carmo is a contract development and manufacturing partner for medical-device components (injection-moulded plastic components, valves, ports and assemblies), not a finished-device manufacturer. Its certified ISO 13485 scope is the design, development, manufacture and assembly of those components; the OEM placing the finished device on the market is the legal manufacturer under MDR (Regulation EU 2017/745). From first prototype through validation builds to regulated volume, your components are developed and produced by one engineering team, with no supplier handover at scale-up.

In medical devices, once you’ve qualified a supplier they’re part of your device for its whole regulated life. Carmo’s medical customer relationships run 20 to 30 years, with components still in continuous production, and the real question is whether that supplier will still be there, and still be the same company, two decades from now.

Carmo has been privately owned in Denmark since 1941, with production in Espergærde. That stability is the point: the company that qualifies your component today is the one still making it when your device is still on the market. And because the same team stays with the component across its life, the changes that inevitably come (a new material regulation, a worn tool that needs replacing, a re-validation) are handled inside your existing supplier qualification. You don’t re-qualify a supplier every few years. You keep the one you have.

Then start from the catalogue. Carmo’s medical-component catalogue includes drainage valves, filler valves, connectors, tube flanges, aeration eyelets, puncture ports, and hangers: proven designs in continuous production for medical bags, ID bracelets, and immobilisation equipment, produced under the certified ISO 13485 QMS. Carmo also runs a standard technical-component catalogue (HF-weldable eyelets, valves, threaded nozzles, snap grommets, drainage fittings) for industrial, maritime, agriculture, cleantech, and rescue applications. Custom variants of standard components are an established intermediate engagement: bring your specific geometry or material adjustment, and the engineering team scopes the variant from a known starting point, faster and lower-risk than full custom development. For full custom development from concept, including unique IP-protected platforms like the Carmo SuperValve™ family built on Carmo’s granted Cross Valve and Turnvalve patents, the larger custom development engagement above is the path.

Yes. Carmo signs a one-way non-disclosure agreement before scoping discussions that involve customer IP, clinical-context detail, or regulatory pathway specifics. A brief one-way NDA covers the scoping conversation; a mutual, project-specific agreement is settled at project start, before development work begins. Turnaround is typically days rather than weeks; contact [email protected] to start the exchange.

Three entry points depending on what you have. If you have a concept but no design yet, bring the problem rather than the specification; Carmo’s design team can work from functional requirements through to a manufacturable component. If you have a design but want to test it in production material before tooling commit, Carmo Print Moulding delivers functional prototypes in days. If you have a component in field service and want to redesign it for cost, durability, or regulatory fit, the integrated team handles redesigns from existing components routinely. In all three cases, contact [email protected] or visit carmo.dk; a brief one-way NDA covers the scoping conversation.