About Carmo

Carmo A/S (CVR 26987369) is a privately held, independent Danish company. The owner is Carmo Holding ApS, and Claus Steenstrup Ishøy is Director. Ownership has passed through three successive, unrelated owners since Carl Mogensen founded the company in 1941: Mogensen (1941–52), Cai Marckman Hansen (1952–97) and Ishøy (1997–today), with independent Danish manufacturing running continuously across all three, more than 80 years in all. No private-equity or parent-group owner sets Carmo’s priorities from outside.

Yes. Carmo has been privately and independently owned for more than 80 years (see “Who owns Carmo?” above), with no private-equity or short-cycle ownership behind it to shift priorities mid-programme. The stability shows operationally too: a certified quality management system since 1993 (ISO 13485 since 2013), customer relationships that commonly run 20 to 30 years, and production in Espergærde with around 85 staff. For the current certificate and scope, see

Carmo’s certified ISO 13485 quality management system covers regulated production: from validation builds through to volume manufacturing of medical components. Rapid prototyping with 3D-printed tooling (Carmo Print Moulding) sits outside the certified scope and runs on project-by-project engineering documentation; the certified QMS engages from validation builds onward. The continuity across that boundary is the engineering team, not the QMS: the same engineers who run your early iterations take the project into definitive tooling, run validation through installation, operational and performance qualification (IQ/OQ/PQ), and take the part into QMS-controlled volume production. For the exact certificate scope, see

Carmo is a component supplier. Under the EU Medical Device Regulation (MDR), legal-manufacturer responsibility for the finished device (clinical evaluation, the technical file, CE marking, post-market surveillance) rests with you, the OEM placing the device on the market. Carmo’s responsibility is the component: design and engineering support, manufacturing under the certified QMS, traceability, and the documentation that supports your device file. That division is deliberate and explicit, so there is no ambiguity about who holds which obligations when you qualify Carmo as a supplier.

Continuity is built into how Carmo operates, not dependent on any single person. Know-how lives in documented engineering and a stable in-house team rather than in scattered individuals or external vendors; the same team carries a project from first iteration through to regulated volume, so project history and hard-won detail are retained across the programme. The track record is the evidence: more than 80 years of continuous private ownership, customer relationships that routinely span 20 to 30 years, and component designs from decades ago still in production today. In regulated medical supply that supplier stability is itself a qualification asset: a qualified supplier stays in place for the device’s regulated life.

Your IP stays yours. Carmo signs a non-disclosure agreement before scoping discussions that involve your product IP or clinical context, and the product design, trade secrets, and regulatory detail you share remain yours under the engagement’s NDA. As a component supplier, Carmo does not develop or sell competing finished devices, so there is no conflict of interest with your product. For how confidentiality works specifically inside a development engagement, see rapid prototyping.