Competency 03 — Surgical Instrument Making

Assembly of Surgical Instruments

In Erchinger's assembly department in Tuttlingen, highly qualified surgical instrument makers assemble every instrument carefully by hand — inspected, documented, and backed by a quality promise: 100% function of every assembled instrument.

EN ISO 13485:2016
FDA Reg. #9611827
100% Functional Testing
Erchinger assembly — surgical instrument maker during hand assembly in Tuttlingen
Assembled in Tuttlingen
Certified
ISO 13485:2016
Registered
FDA Contract Mfr.
Definition

What assembly of surgical instruments means at Erchinger.

The assembly of surgical instruments is the final manufacturing step, in which individual precision components are assembled by hand into a functional instrument by qualified surgical instrument makers. At Erchinger, this includes the assembly of complex instruments, the integration of fine-mechanical and moving components, and the final inspection of functionality, fit and safety — before packaging, marking and delivery.

  • Manual assembly of surgical instruments by experienced surgical instrument makers
  • Inspection of functionality, fit and safety for every instrument
  • Integration of fine-mechanical and moving components into complex assemblies
  • Packaging, marking and preparation for delivery under your brand

"Quality begins in assembly — craftsmanship from master hands. We guarantee 100% function of every assembled instrument."

Erchinger AG — Assembly, Tuttlingen
At a Glance

Erchinger as an assembly partner for surgical instruments

Craftsmanship precision, tested function and complete documentation — Erchinger handles final assembly of surgical instruments from prototype to series.

  • LocationTuttlingen — centre of German medical technology
  • CertificationEN ISO 13485:2016
  • RegistrationFDA-registered Contract Manufacturer
  • Skilled staffQualified surgical instrument makers
  • Inspection100% functional and visual inspection
  • ScopeAssembly, packaging & marking
The Process in Brief

From inspected components to a released instrument.

Components From Manufacturing
We take the inspected, released individual parts from our own manufacturing — fully documented and traceable.
Hand Assembly & Inspection
Qualified surgical instrument makers assemble every instrument by hand and check function, fit and safety.
Packaging & Delivery
After final release, the instrument is packaged, marked and delivered under your brand with full documentation.
Our Assembly Expertise

Expert final assembly at a glance.

From assembly of components to delivery — our services in detail.

Assembly of Components

Assembly of complex instruments from multiple precision components to customer drawing or development specification.

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Assembly of Components

Multi-part instruments with a ratchet function, joints or sliding mechanisms are assembled by hand step by step and continuously checked for fit.

Fine-Mechanical Integration

Installation of moving and fine-mechanical components such as joints, ratchet functions and spring mechanisms.

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Fine-Mechanical Integration

Springs, ratchets and joints must show exactly the intended force and movement after assembly — our surgical instrument makers check this individually on every instrument.

Functional & Visual Inspection

Inspection of functionality, fit and safety for every single assembled instrument.

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Functional & Visual Inspection

Every instrument is checked for smooth movement, secure fit and flawless appearance before leaving assembly — the basis for our 100% function promise.

Documentation & Traceability

Complete documentation of every work step in the Device History Record (DHR) for full traceability.

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Documentation & Traceability

From component batch to final inspection, every assembly step is recorded — so every delivered instrument can be traced back to manufacturing.

Packaging & Marking

Preparation for delivery including packaging and marking to customer requirements.

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Packaging & Marking

Whether individual packaging or set assembly: we package and mark to suit your target market and your requirements for sterilisation and logistics.

Small & Large Series

Flexible assembly capacity from prototype assembly to ongoing series production.

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Small & Large Series

Our assembly department scales from single-unit prototype production to continuous series assembly — with no difference in quality between the first and the thousandth piece.

Assembly Project Process

How assembly works at Erchinger.

Five steps from inspected individual parts to delivery.

01

Receipt of Inspected Components

We receive the inspected individual parts released from manufacturing into assembly. Every batch is documented and fully traceable. This means every assembly begins from a basis of verified quality.

02

Assembly of Components

Qualified surgical instrument makers assemble the instruments carefully by hand to the customer drawing. Fine-mechanical and moving components are fitted precisely. Every step follows a defined work standard.

03

Functional Testing

Every assembled instrument is checked for functionality, fit and safety. Moving parts must operate smoothly and lock securely. Only flawless instruments pass this test.

04

Documentation

Every assembly and inspection step is fully recorded in the Device History Record (DHR). This creates full traceability for every single instrument. This documentation is part of our certified quality management system.

05

Packaging & Delivery

After final release, every instrument is packaged and marked for delivery. Delivery is fully documented and made under your brand. This completes the circle, from manufacturing to a ready-to-use product.

Details for Your Planning

Craftsmanship, inspection processes & quality, in detail.

In-depth information about our assembly department — click to expand.

Craftsmanship from master hands

Highly qualified surgical instrument makers work in the assembly department in Tuttlingen, many with decades of experience. Every instrument is carefully assembled by hand, inspected, and tested to the individual customer's requirements — a quality promise that customers worldwide rely on.

Integrated processes with development & manufacturing

Assembly at Erchinger is closely linked with the other core competencies: development, optimisation and manufacturing. Technicians and engineers coordinate assembly requirements as early as the design phase for an optimal end result — reducing sources of error and saving cost and time.

Quality assurance & documentation

Assembly is carried out under strict quality guidelines and is part of the quality management system certified to EN ISO 13485:2016. Every assembly step is documented and checked — for complete traceability and maximum product safety.

Packaging, marking & delivery

Following successful inspection, instruments are packaged, marked and prepared for delivery — under the customer's brand where required. Through holistic project management, Erchinger guarantees short throughput times and high delivery reliability.

Where Precision Parts Become an Instrument

Assembly that must work one hundred percent in theatre.

Every instrument that leaves our assembly in Tuttlingen has been inspected and released by hand. This rigour in inspection, documentation and craftsmanship is what sets assembly at Erchinger apart from mere putting-together — regardless of whether it's a single unit or an ongoing series.

Key facts at a glance
EN ISO 13485:2016
FDA Reg. #9611827
100% Functional Testing
Complete DHR Documentation
Every assembly project at Erchinger goes through the same validated inspection chain — for 100% function of every single instrument.
Certification
EN ISO 13485:2016
FDA Registration
Contract Manufacturer #9611827
Location
Tuttlingen — centre of medical technology
Erchinger assembly 1 — hand assembly in Tuttlingen
Erchinger assembly 2 — hand assembly in Tuttlingen
Erchinger assembly 3 — hand assembly in Tuttlingen
Erchinger assembly 4 — hand assembly in Tuttlingen
Frequently Asked Questions About Assembly

Concrete answers for your project planning.

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 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.

Does Erchinger also assemble complex assemblies with moving parts?

Yes. The assembly department integrates fine-mechanical and moving components into complex instrument assemblies, from simple grasping forceps to multi-part systems with a ratchet function.

Does Erchinger also handle packaging and marking?

Yes. Assembly services include packaging, marking and preparation for delivery — matched to the requirements of the relevant customer and target market.

How is assembly integrated with development and manufacturing?

Development, manufacturing and assembly all run under one roof at Erchinger. Technicians and engineers coordinate assembly requirements as early as the design phase for an optimal end result — maximising efficiency and quality.

Does Erchinger assemble small quantities or only series?

Erchinger assembles prototypes, small batches and large series alike. Assembly capacity is flexibly adapted to the relevant project phase, from single-unit production to ongoing series production.

Let's Talk About Your Project

Ready for your assembly?

Whether a prototype, small batch or ongoing series production — our surgical instrument makers assemble, inspect and document your instrument through to 100% functional release.