Implants, medical instruments and components for medical devices. With sterile packaging. Verified in accordance with ISO 13485 and FDA.
Plastics and metals for medical technology
Your products are used in and around people to protect the most precious commodity of them all – our health! That is why it is crucial to ensure that every step of the manufacturing process is validated and documented for seamless verifiability.
Verified quality and a comprehensive range of services
To make sure we can meet your requirements, we undergo continuous independent audits, confirmed by our ISO 13485 certification, as well as inspections by the US Food and Drug Administration (FDA).
As a solution-oriented partner with skills that stretch throughout the value creation chain, we meet your expectations head on, from advice on materials to production, surface refinement, cleaning and assembly, right through to the sterile, packaged product – all from a single source.
Thanks to the availability of a range of plastics and metals approved for medical technology, we always use the ideal material for your application.
Production of your components: quick, safe, clean and faultless
A modern machine pool with qualified machines, validated processes plus trained staff with verifiable qualifications mean that we can guarantee production with the highest level of precision and quality.
The cleanliness of the production environment used to manufacture your medical products is protected by carefully coordinated cleaning systems, work processes and process media.
Depending on your requirements, cleaning includes pre-cleaning, precision cleaning and final rinsing.
The products are then installed and packaged in an ISO class 7 cleanroom. Blister packaging or bags are used to keep germs to a minimum and are labelled according to your needs.
On request, we can also integrate sterilisation processes, such as gamma radiation, plasma and ethylene oxide, into our process chain.
Spinal implants made from PEEK are processed dry to minimise the risk of contamination. X-ray transparent implants contain tantalum markers for monitoring their position.
Depending on the application or operation process/system, both plastics and metals are used for inserts. If metals are used, then suitable stainless steels are applied. Following production, the parts run through a range of surface treatments to achieve the ideal finish.
Spot film devices
Spot film devices are usually used when inserting bone plates. These spot film devices are high-precision instruments that require a maximum degree of accuracy, strength and stability, particularly because they are used multiple times and therefore require repeat sterilisation (and as a result are frequently subject to high temperatures). Further criteria include biocompatibility, X-ray transparency and easy handling for the surgeon. In the majority of cases, a material consisting of PEEK and a carbon fibre mesh is used for these devices.