Frequently Asked Questions

Answers about Erchinger.

All the key questions about contract manufacturing, development, manufacturing, assembly, our product lines and quality standards — gathered in one place.

Contract Manufacturing & Competencies

What is contract manufacturing of surgical instruments?

Contract manufacturing (also OEM manufacturing) refers to the production of surgical instruments to a customer's specifications, without the manufacturer itself acting as the brand owner. Erchinger takes on development, manufacturing, assembly and documentation, while the product is delivered under the customer's brand.

What services does Erchinger cover as a contract manufacturer?

Erchinger covers the entire manufacturing process for surgical instruments: development and design, CNC manufacturing, assembly, as well as bespoke special solutions (ER Solution) and series products (ER Line) for spinal surgery, proctology and cannulas & suction tubes.

From what batch size does Erchinger manufacture?

Erchinger manufactures from batch size 1 — from single-unit production through small batches to ongoing large-scale series production. Capacity is flexibly adapted to the relevant project phase.

Development

What does the development of a surgical instrument cost?

Costs depend on complexity, specialism and the scope of design work required. Following a no-obligation initial conversation, Erchinger prepares a bespoke quote covering feasibility assessment, CAD design and prototyping.

Does Erchinger also offer reverse engineering without existing drawings?

Yes. Erchinger technically reconstructs existing surgical instruments even without existing design documentation and converts them into manufacturing-ready CAD models.

Manufacturing

Which manufacturing processes does Erchinger use?

Erchinger manufactures using 5-axis and 4-axis milling machines, long-bed and short-bed automatic lathes, surface grinding machines, rotary swaging machines, and processes such as TIG welding, laser welding and laser marking. The portfolio is complemented by additive manufacturing (SLM) for rapid prototyping.

What materials are processed?

Erchinger processes the materials typically used in surgical instrument making, particularly stainless surgical steels and titanium alloys, finished through processes including grinding, brushing, high-gloss polishing, and coatings such as TiAlN, AlCrN or anodising.

Assembly

Who assembles the surgical instruments at Erchinger?

Assembly is carried out by highly qualified surgical instrument makers in Tuttlingen, many with decades of experience. Every instrument is carefully assembled by hand, inspected, and tested to the individual customer's requirements.

How is the function of every assembled instrument ensured?

Every assembled instrument goes through a visual and functional inspection for fit, movement and safety. Erchinger guarantees 100% function of every assembled instrument — documented and traceable.

ER Solution & ER Line

What is the difference between ER Solution and ER Line?

ER Solution stands for the bespoke new development of a surgical instrument for a specific, as yet unmet need. ER Line comprises already established, series-manufactured instrument ranges for spine, proctology, and cannulas and suction tubes, adapted to customer specification.

Does my instrument design remain my company's intellectual property?

Yes. Erchinger develops exclusively to customer order and does not bring competing products of its own to market. Projects are treated confidentially, typically under a non-disclosure agreement (NDA).

Quality, Certification & Company

What certifications does Erchinger AG hold?

Erchinger is certified to EN ISO 13485:2016 and registered as a Contract Manufacturer with the FDA (#9611827). All processes are regularly revalidated.

What do DHR and DMR mean?

Device History Record (DHR) and Device Master Record (DMR) are manufacturing records that fully document every manufacturing and inspection step of an instrument. Erchinger maintains these records professionally and makes them available for your approval documentation as needed.

Since when has Erchinger AG existed and who owns it?

Erchinger AG was founded in Tuttlingen in 1949 and has been part of the Swiss WISTAMA AG since 2021. Before that, the company was family-owned for three generations.

Where is Erchinger AG based?

Erchinger AG is based at Rudolf-Diesel-Straße 20, 78532 Tuttlingen — in the internationally recognised centre of German medical technology.

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