Beutter Präzisions-Komponenten GmbH & Co. KG of Rosenfeld at COMPAMED 2021 in Düsseldorf -- MEDICA - World Forum for Medicine
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Beutter Präzisions-Komponenten GmbH & Co. KG

Butzensteigleweg 4-6, 72348 Rosenfeld
Germany
Telephone +49 7428 933-0
Fax +49 7428 933-290
office@beutter.de

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This company is co-exhibitor of
IVAM Microtechnology Network

Hall map

COMPAMED 2021 hall map (Hall 13): stand E47

Fairground map

COMPAMED 2021 fairground map: Hall 13

Our range of products

Product categories

  • 01  Manufacturing of components
  • 01.04  Metal machining processing
  • 01.04.03  Metal cutting, chip removal

Our products

Product category: Metal cutting, chip removal

Components for medical technology

Vital precision
Components for medical technology are subject to special requirements in terms of quality assurance methods, production and process monitoring. BEUTTER has decades of experience with these very sensitive products.

We manufacture components for medical devices, instruments and implants:
Components for osteosynthesis and endoprosthetics
Components for active implants such as pacemakers, cardiovascular support systems, hydrocephalus valves and port systems
Prosthetic and orthotic components
Single parts and complete systems for surgical instruments
In the case of instruments for traumatology, we work closely with the company Medizin Mechanik Nord. We manufacture self-holding and torque-limited screwdrivers for our partner: www.medizin-mechanik.de.

Materials for medical technology, especially where tissue contact takes place, must meet high requirements in terms of biocompatibility and fatigue resistance. Special processing requirements are taken into account for these materials.

BEUTTER processes for components for medical technology, among other things, special materials and materials such as:
  • Implant steels, such as 1.4441
  • Cobalt-based alloys
  • Rex 734
  • Elgiloy
  • Titanium, especially Grade 5 (ELI)
  • Precious metals, such as Pt-Ir, palladium
  • Biocompatible plastics, such as PEEK
We will document the entire development and manufacturing process, including complete traceability from the starting material to the finished product as well as plant qualification and process validation.

Our quality management certificate DIN EN ISO 13485 includes implants of risk class III. With the amendment of ISO 13485:2016 we will adapt our quality management according to the requirements of the FDA within the scope of 21 CFR Part 820.

Our production facilities, on which we manufacture turned and milled parts for medical technology, are partly used exclusively for this product class. Where this is not possible, we carry out high-quality product cleaning to ensure product cleanliness and low particle levels. It is thus a prerequisite for final cleaning and for physical and chemical product sterilization and sterile packaging. Together with our customers we develop medical products, manufacture prototypes and prepare the complete development documentation.

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Product category: Metal cutting, chip removal

BEUTTER supports you in the development of your precision components

From the sketch to the finished product
As a specialist in the manufacture of precision parts, BEUTTER offers the full range of services for its customers
from the sketch of a product to production and functional tests. Although we see ourselves primarily as a manufacturer, we accompany our customers through all phases of a project. In doing so, we employ specialists with experience in the industry and guarantee economical and rational project handling. BEUTTER guarantees strict confidentiality, additionally contractually secured if required.

BEUTTER supports you in the development of your precision components:
Advice on the development and design of components
Execution of designs, especially in the field of medical technology with development documentation and risk analysis
Data transfer with Solid Works
Reliable processing and documentation of even extensive projects
Execution of test series and calibration cycles

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Product category: Metal cutting, chip removal

Subassembly production and subassembly assembly / small parts production

From development to assembly
We develop and design assemblies and entire devices together with our customers and implement this design as prototypes and in series production. For existing designs, we support our customers in making them ready for production, selecting materials and tolerancing. They benefit from our extensive know-how in all manufacturing processes.

BEUTTER uses all assembly methods, including gluing, soldering, welding (e.g. with laser or electron beam), whereby we partly rely on qualified suppliers. We assemble subassemblies and entire devices, including electrical, electronic, pneumatic and hydraulic components.

In consultation with our customers, we carry out functional tests and endurance tests with the necessary documentation. If necessary, we determine specific functional parameters and measure components.

For example, we manufacture components and assemblies in miniaturized design for the following applications:
Components for active medical implants
Instrument components for minimally invasive surgery
Components for precision measuring instruments
Individual parts and assemblies for sensor systems

The highest quality materials are often used for small parts:
Precious metal alloy
Titanium in all grades
Physiologically inert materials
Autoclavable high-performance plastics
We are happy to offer assistance in selecting materials and getting your designs ready for production.

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About us

Company portrait

The Beutter company is a supplier of precision mechanical components. The focus is on individual parts and assemblies with high manufacturing requirements and a high degree of vertical integration, preferably made of materials that are difficult to machine. Medical technology is one of the central target industries, in addition to important customers from mechanical engineering, aerospace, measurement and sensor technology and defence technology.

With currently 150 employees, 20 of which are trainees, and a proportion of skilled workers of about 80 %, Beutter is already one of the somewhat larger supplier companies. This represents an advantage for the requirements of medical technology. Not only does it mean that the necessary resources and specialist personnel are available to implement regulatory requirements, but it also means that the necessary specialist contacts can be maintained with medical technology manufacturers. These are so important because some requirements for medical devices are difficult to document and the necessary understanding of issues between both partners requires sound communication.

Beutter has all machining processes (turning, milling, grinding, honing) for the production and processing of complex turned parts, milled parts and assemblies, their assembly as well as cleaning and packaging in the clean room. Both prototypes and small series up to medium series of several 1,000 units per batch can be manufactured. In addition to the use of machining centres, emphasis is also placed on manual or partially automated operations, for example for deburring, polishing, cleaning and packaging. Processes that cannot be carried out in-house are handled by qualified suppliers. The entire production process is accompanied by a quality control system that covers all metrological tasks during production and final inspection. Subcontractors are also integrated into this system.

In addition to the qualification according to ISO 13485:2016, which is technically necessary for medicine, Beutter is certified according to ISO 9001 and for aviation according to EN 9100. In addition, there are numerous company approvals.

Beutter manufactures for many areas of application in medical technology, but sees its focus in particular in the area of implants of risk classes IIb and III.