Certified 3D printing service 

Many industries are already benefiting from the advantages of Additive Manufacturing but are also subject to specific requirements and regulations. Our focus is on materials and 3D printed components for applications in the medical, aerospace and railway industries. Our materials and printers are tested and approved according to industry requirements.

Certified Medical 3D Printing

Medical technology applications are subject to particularly strict regulations and requirements. Our system for Additive Manufacturing includes qualified machines according to ISO13485:2016 including IQ & OQ as well as materials tested and certified on the machine.
We thus offer solutions explicitly for medical technology that have been tested or evaluated for biocompatibility in accordance with standard ISO 10993-1, -4, -5, -18. These fulfill the specified requirements for contact of up to 24 hours with skin and tissue and, if necessary, indirect contact with blood. The following tests for biocompatibility are usually performed on the 3D-printed part:

  • Cytotoxicity / growth inhibition (ISO 10993-5)
  • Haemolysis (ISO 10993-4)
  • Chemical analysis / fingerprinting (ISO 10993-18) 
  • Biotoxicological evaluation (ISO 10993-1)

Qualified systems for additive manufacturing in aerospace & railway

High safety and flame retardant materials are essential in the aerospace and rail industries. Our Additive Manufacturing enables the production of 3D printed components that are qualified for use in the aerospace and railway industries. In the aerospace and rail industries, the highest levels of safety and flame-retardant materials are essential. We enable the production of aerospace and railway qualified 3D printed parts with our Additive Manufacturing. 
Qualified machines and machine-tested as well as certified materials are part of our validated aerospace and railway additive manufacturing system. This allows us to offer aerospace and railway solutions that meet the requirements of FAR 25.853 for aerospace and EN 45545-2 for railway material standards.

  • Flammability testing with 60 second and / or 12 second vertical fire test
  • Optical smoke density / smoke emission testing
  • Determination of combustion or gas toxicity of fumes
  • Determination of heat release during fire
  • Flammability 15 second horizontal fire test

Certified 3D Printing Material

With our own compounding and filament extrusion facilities, we can also produce and process industry-specific, qualified materials in-house.