Medical Products Supplies Companies

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

Product Categories

Product categories

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

Metal cutting, chip removal

Components for medical engineering

Our products

Product category: Metal cutting, chip removal
Components for medical engineering
Life-critical precision

Medical engineering components are subject to very specific requirements in terms of their methods of quality assurance, manufacture and process monitoring. BEUTTER has decades of experience with these very sensitive products.

We produce components for medical equipment, instruments and implants:

Components for osteosynthesis and endoprosthetics
Components for active implants such as pacemakers, cardiac circulation support systems, hydrocephalus valves and port systems
Prosthetics and orthotic components
Components and complete systems for surgical instruments

For instruments for traumatology we work closely together with the company Medizin Mechanik Nord. We manufacture self-holding and torque-limited screwdrivers for our partner: www.medizin-mechanik.de

Materials for medical engineering, especially where bodily tissue contact is involved, must satisfy stringent requirements in terms of bio-compatibility and fatigue strength. For these materials, highly specific machining specifications are observed.

For medical engineering components, BEUTTER processes various materials, including the following:

Implant steels such as 1.4441
Cobalt-based alloys
Rex 734
Elgiloy
Titanium, especially Grade 5 (ELI)
Precious metals such as Pt-Ir, palladium
Bio-compatible plastics such as PEEK

We document the entire development and manufacturing process. This includes seamless traceability, from initial material to finished product, as well as plant qualification and process validation.

Our quality management certificate DIN EN ISO 13485 includes implants in risk class III. With the updating of ISO 13485, we shall adapt our quality management to comply with the stipulations of the FDA in the context of 21 CFR Part 820.

A fair proportion of the production plant on which we manufacture components for the medical technology sector, is used exclusively for this class of product. Where this is not possible, we clean products to an extremely high standard, assuring product cleanliness and low particulate content. This is a requirement for final cleaning and for physical and chemical product sterilization and sterile packaging.

Together with our customers, we develop medical products, we produce prototypes and we produce the complete range of development documentation.

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About Us

Company details
Your precision supplier
As your partner for the delivery of precision mechanical components, we can offer you everything from development to production of individual parts and sub-assemblies, up to the assembly of complete items of equipment.

We like to set ourselves challenges – especially with the manufacture of short production runs, and extremely difficult components made of materials that are difficult to machine.

Company data
Number of employees

100-499
Foundation

1909
Area of business

Manufacturing Services

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