Erchinger develops, manufactures and assembles surgical instruments on behalf of MedTech companies — regulated, fully documented, and from batch size 1. You supply the specification or idea; we deliver the release-ready product under your brand.
Contract manufacturing — also known as OEM manufacturing — describes a manufacturing model in which a specialist partner develops and produces goods exactly to a customer’s requirements, without appearing as the brand owner in the end market. For MedTech companies, that means: Erchinger takes on design, manufacturing, assembly and the associated regulatory documentation, while the finished surgical instrument is delivered under the customer’s brand.
"You supply the requirement — we deliver the documented, release-ready instrument."
Erchinger is a specialist contract manufacturer of surgical instruments based in Tuttlingen — regulated, certified, and available from batch size 1.
Erchinger takes responsibility for every phase itself — with no loss of continuity between design, manufacturing and assembly. You speak to one point of contact, whatever stage your project is at.
Starting from a drawing, a requirements brief, or even a still-open idea, we work with you to develop a manufacturing-ready solution. Our design engineers check every geometry for manufacturability (Design for Manufacturing) before a prototype is built — saving later iteration loops and securing series readiness from the outset. We also optimise existing instruments specifically for manufacturing cost, service life or ergonomics, without changing their function.
In manufacturing, we rely on modern machinery and skilled staff with years of experience in surgical instrument making — from CNC milling and turning to grinding and surface treatment. We process the materials typically used in instrument making, including stainless surgical steels and titanium alloys. Every manufacturing step is documented, reproducible and regularly revalidated — the basis for consistent quality across every batch size.
Experienced surgical instrument makers assemble every instrument by hand, checking function, movement and dimensional accuracy before release. Where required, assembly takes place under cleanroom conditions. The process concludes with complete documentation via Device History Record (DHR) and Device Master Record (DMR) — traceable down to the last detail before the instrument is delivered under your brand.
Every instrument that leaves our works in Tuttlingen goes through the same validated process steps — regardless of batch size or specialism. This consistency in material selection, manufacturing and documentation is what sets contract manufacturing at Erchinger apart from mere supply.
Erchinger manufactures exclusively for medical technology companies — not for clinics or purchasing groups. Flip the cards for the story behind each starting point.
Second-source qualification with no change to form, function or approval — including full process documentation for your supplier audit.
Erchinger takes on second-source qualification of your existing drawing with no change to form, function or approval — including full process documentation for your supplier audit.
Support from the very first feasibility assessment — even for small quantities and with no minimum order in the development phase.
We support you from the first feasibility assessment through to a validated prototype — even for small quantities and with no minimum order for the development phase.
FDA-registered and EN ISO 13485 certified — the evidence you need for a second or third source of supply in your audit.
As an FDA-registered and EN ISO 13485-certified manufacturing partner, we provide the evidence your supply-chain audit requires for a second or third source of supply.
Six steps from first enquiry to delivery under your brand.
Initial conversation on requirements and timescale, protected where needed by a non-disclosure agreement (NDA).
Review of design and manufacturability (DFM), agreement on cost framework and schedule.
CAD design, prototyping and initial test samples to validate function and ergonomics.
Process validation, first-article inspection and release for stable series manufacturing.
CNC manufacturing and expert assembly by experienced surgical instrument makers, in a cleanroom where required.
Complete DHR/DMR documentation, delivery of the release-ready product under your brand.
Erchinger manufactures from batch size 1 — from a single custom instrument to multi-stage series production of established product lines. The manufacturing strategy is agreed with the customer on a project-specific basis.
Duration depends on complexity: an optimisation project on an existing instrument can be brought to series readiness within a few weeks, while a new development from first sketch to validated series manufacturing typically takes several months — including prototyping, first-article inspection and process validation.
Erchinger processes the materials typically used in surgical instrument making, including stainless surgical steels and titanium alloys, matched to the application, sterilisation method and mechanical demands of each instrument.
The terms are broadly used interchangeably. Both describe a manufacturing partner producing goods to the specifications and on behalf of its customer, without bringing its own brand to market. Erchinger uses both terms for the same service model.
It starts with a no-obligation initial conversation to clarify requirements, timescales and, where relevant, a non-disclosure agreement (NDA). Erchinger then assesses technical and manufacturing feasibility and prepares a concept for development or transfer into series production.
Both. Erchinger undertakes new development of surgical instruments based on an idea or requirement, as well as optimisation and series manufacturing of already existing designs and drawings.
Whether it's new development, series optimisation or complete contract manufacturing — we listen, assess feasibility, and deliver a documented, release-ready product under your brand.
