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
- 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.