Competency — Development · Manufacturing Engineering

Development of Surgical Instruments

Core competency in manufacturing engineering — intelligent solutions for surgical instruments from Erchinger AG Tuttlingen. As an experienced production service provider and OEM contract manufacturer, we offer bespoke solutions for the technical optimisation, production and assembly of medical instruments. Our expertise begins not just at the machine — but already at the manufacturing-engineering development of your requirements.

EN ISO 13485:2016
FDA Reg. #9611827
3D CAD & CAM Systems
Erchinger development — design engineer comparing an instrument with the CAD design
Certified
ISO 13485:2016
Registered
FDA Contract Mfr.
Our Manufacturing Engineering

Design with a system — the solution to your requirements.

We see manufacturing preparation as a holistic process. From the technical review of your concepts through reverse engineering to series-ready optimisation, our experienced technicians support your project with the highest level of commitment. Precise implementation of your specifications for clinical use always remains the focus.

Whether you are delivering a new product or want to optimise an existing instrument from a manufacturing standpoint — we deliver solutions that convince both technically and economically. As an experienced production service provider and OEM contract manufacturer for surgical instruments, Erchinger AG in Tuttlingen offers bespoke solutions for the technical optimisation, production and assembly of medical instruments.

  • Technical consulting and feasibility assessment
  • Support with functional and design requirements
  • Manufacturing-engineering implementation to customer specification
  • Design optimisation of existing products
  • CAD-based design solutions for prototypes and series models
  • Support with approval and documentation to MDR requirements

"Our expertise begins not just at the machine — but already at the manufacturing-engineering development of your requirements."

Erchinger AG — Development Competency
At a Glance

Development — Competency Profile

From technical review to series-ready optimisation — manufacturing engineering under one roof.

  • SpecialismsOpen surgery, spine, proctology
  • Systems3D CAD & CAM
  • CertificationEN ISO 13485:2016
  • RegistrationFDA-registered Contract Manufacturer
  • DocumentationDHR & DMR
  • LocationTuttlingen — centre of medical technology
From Prototype to Series Manufacturing — Under One Roof

Your requirements, precisely transferred into series.

Fast Delivery
Fast delivery of prototypes — based on existing documentation or through the creation of technical manufacturing documentation to your requirements.
Efficient Transfer to Series
Efficient transfer into series production through the close integration of technical work preparation, production and assembly.
Close Coordination, OEM-Ready
Close coordination between engineering and manufacturing, along with OEM-ready processes with clearly defined interfaces — for short delivery times and transparent processes.
The Path From First Conversation to Series Readiness

Your development enquiry at Erchinger.

From technical consulting to a CAD-based design solution — the key services along the way.

01

Technical Consulting & Feasibility Assessment

It starts with technical consulting and a feasibility assessment of your concept, complemented by support in clarifying functional and design requirements. Our expertise thus begins even before the actual design work — not just at the machine.

02

Manufacturing-Engineering Implementation

The manufacturing-engineering implementation of surgical instruments follows your specification — including design optimisation for existing products. Our experienced technicians support this step with the highest level of commitment, always with a focus on the precise implementation of your specifications for clinical use.

03

CAD Design Solution for Prototype & Series

Next comes the creation of CAD-based design solutions — for the prototype, and already with the later series model in mind. Our modern machinery enables the fast, cost-effective transformation of your requirements into precise surgical instruments.

04

Approval & Documentation

In parallel, we support you with approval and documentation, for example to MDR requirements — including DHR- and DMR-based manufacturing records. This keeps every manufacturing step fully traceable and your instrument documented to standard.

What We Stand For

Quality, certification and complete documentation.

Three foundations of our development expertise that run through every project — from the first technical consultation to the fully assembled series. Flip the cards for more detail.

Quality

All processes are validated to EN ISO 13485:2016 and regularly revalidated.

↻ Flip for more
01

All processes are validated to EN ISO 13485:2016 and regularly revalidated.

Certification

Registered as a Contract Manufacturer with the FDA (#9611827) and certified to EN ISO 13485:2016.

↻ Flip for more
02

We are registered as a Contract Manufacturer with the FDA (#9611827) and certified to EN ISO 13485:2016.

Technical Manufacturing Documentation

Professional maintenance of DHR- and DMR-based manufacturing records for the highest process reliability.

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03

Professional maintenance of Device History Record (DHR) and Device Master Record (DMR) based manufacturing records for the highest process reliability.

Technical Expertise & Industry-Specific Know-How

Instruments that meet the demands of everyday clinical use.

Our specialists have in-depth knowledge of surgical instrument technology — particularly in open surgery, spinal surgery and proctology. By combining high qualifications, years of experience and technological innovation, we develop instruments that meet the demands of everyday clinical use. This specialist depth feeds directly into every technical consultation, every feasibility assessment and every design optimisation we carry out for our customers.

Key facts at a glance
Open Surgery
Spinal Surgery
Proctology
Quality, Reliability & Punctuality — Our Standard

Our service does not end with the technical drawing.

We support your project through to final assembly and beyond. At Erchinger AG, service does not end with the technical drawing.

What we value most

Excellence in product quality

Reliable delivery dates

Validated manufacturing processes to EN ISO 13485:2016

Complete traceability and full documentation (DHR)

Internal Reviews & Quality Testing

Through regular internal reviews and quality testing, we ensure your instrument meets your requirements exactly — functionally, economically and to the required standard.

Why Erchinger AG?

Decades of experience in the technical implementation of surgical instruments

Highest level of expertise as an OEM partner for bespoke manufacturing solutions

Short delivery times through close integration of engineering, manufacturing & assembly

Location advantage: Tuttlingen — centre of medical technology

Modern environment with 3D CAD and CAM systems

Focus on quality, precision and customer orientation

Location: Rudolf-Diesel-Straße 20, 78532 Tuttlingen, Germany

Phone: +49 (0) 7461 96625-0 · service@erchinger.de

Your Contact: Sabine von Döllen (Authorised Officer)

Frequently Asked Questions About Development

Concrete answers for your project planning.

The most important questions about our manufacturing engineering — from the first feasibility assessment to documentation to MDR requirements.

What does Erchinger AG's manufacturing engineering cover?

As an OEM contract manufacturer, Erchinger offers bespoke solutions for the technical optimisation, production and assembly of medical instruments. This expertise begins at the manufacturing-engineering development of your requirements, not just on the shop floor.

What technical services does Erchinger offer in development?

These include technical consulting and feasibility assessment, support with functional and design requirements, manufacturing-engineering implementation to customer specification, design optimisation of existing products, CAD-based design solutions for prototypes and series models, and support with approval and documentation to MDR requirements.

How does the path from prototype to series manufacturing work?

Erchinger's modern machinery and high in-house manufacturing depth enable the fast, cost-effective transformation of requirements into precise surgical instruments — based on existing documentation or through the creation of technical manufacturing documentation to customer specification.

In which medical specialisms does Erchinger have development know-how?

Erchinger's specialists have in-depth knowledge of surgical instrument technology, particularly in open surgery, spinal surgery and proctology.

What quality standards apply to development?

All manufacturing processes are validated to EN ISO 13485:2016 and are regularly revalidated. Erchinger is registered as a Contract Manufacturer with the FDA (#9611827). Device History Records (DHR) and Device Master Records (DMR) are maintained professionally.

Get Advice Now — Your Development in Safe Hands

Do you have an idea for a new surgical instrument?

Or would you like to optimise an existing product? Erchinger AG in Tuttlingen is your experienced partner for the technical delivery, production and assembly of surgical instruments — from the first prototype to series manufacturing. As a contract manufacturer for instruments in spine, proctology and surgery, we stand for "You expect our solution" — your requirement is our starting point, not our own product idea.