Components for the Medical technology.
Vital precision: components for medical technology are subject to special requirements regarding quality assurance, manufacturing and process monitoring. BEUTTER has decades of experience with these very sensitive products, from the instrument to the active implant.
EN ISO 13485
Hinweis: Aktuell dienen die 3D-Modelle als Platzhalter. Sobald echte CAD-Daten vorliegen, werden sie durch die realen BEUTTER-Bauteile ersetzt.
We have all machining processes in-house and specialise in the high-quality manufacture of individual parts, components and assemblies with a high vertical range of manufacture. We carry out heat treatments and surface coating processes via customer-specified or our own audited and validated sub-suppliers. We thus cover the entire supply chain and are your competent point of contact from the initial enquiry to the finished product.
Implants & Endoprosthetics
- Components for active implants such as pacemakers, circulatory support systems, hydrocephalus valves and port systems
- Components for osteosynthesis and joint replacement
- Prosthetic and orthotic components
Surgical instruments
- Components and complete systems for surgical instruments
- On request, assembly of functional subassemblies
- Consideration of special processing instructions
Highest standards
- On biocompatibility and fatigue strength
- Special care with tissue contact
- 100 % inspection in the testing laboratory
Purity & Documentation
- High cleanliness requirements down to sterile packaging
- End-to-end plant qualification and process validation
- Complete traceability
- X-ray fluorescence analysis
„Where tolerances in Micrometer-area decide on function and safety."
For over 115 years, BEUTTER has been manufacturing components that medical technology manufacturers rely on — fully traceable and certified to DIN EN ISO 13485.
Haben Sie eine Zeichnung oder ein Bauteil?
Senden Sie uns Ihre Anforderungen — wir prüfen Machbarkeit, Werkstoff und Fertigung und melden uns mit einer kostenlosen Ersteinschätzung.
BEUTTER processes, amongst others, these materials for medical technology components:
We document the entire development and manufacturing process of medical technology components. This includes complete traceability from the raw material to the finished product, as well as equipment qualification and process validation. Our DIN EN ISO 13485:2016 quality management certificate specifically covers risk class III implants.
Our manufacturing facilities for medical technology are used almost exclusively for this product class. Where this is not possible, we carry out high-quality product cleaning that ensures product cleanliness, a low particle count and biocompatibility.
René Meier
72348 Rosenfeld
Your medical technology project at BEUTTER.
From development through to the prototype and validated series — we support you with our comprehensive know-how and a free problem analysis by our experts.
According to which standard is BEUTTER certified for medical technology?
The quality management system of BEUTTER is certified for medical devices in accordance with DIN EN ISO 13485:2016. The certificate specifically covers risk class III implants.
Which medical technology components does BEUTTER manufacture?
BEUTTER manufactures components for osteosynthesis and endoprosthetics, components for active implants such as pacemakers and port systems, prosthesis and orthosis components, as well as individual parts and complete systems for surgical instruments, amongst other things.
What materials are used for medical technology components?
Among the materials used are implant steels such as 1.4441, titanium Grade 5 (ELI), cobalt-based alloys, Rex 734, Elgiloy, precious metals such as Pt-Ir and palladium, and biocompatible plastics such as PEEK.
How does BEUTTER ensure traceability and cleanliness?
The entire manufacturing process is documented — including complete traceability from the raw material to the finished product, equipment qualification and process validation. The manufacturing facilities are used almost exclusively for medical devices; otherwise, high-quality product cleaning ensures cleanliness, low particle levels and biocompatibility.
Have you got a drawing or a component?
Send us your requirements – we will check feasibility, material and production and get back to you with a free initial assessment.