Certification/Quality management

 
 
 
 
 
 
 
 
deutsch     Legal Notice E-mail to 3di

Our corporate strategy makes our customer's satisfaction the main concern of all our entrepreneurial actions. We want to convince you with quality products. This we are also willing to document publicly.

Since 08/21/2002 we are certified according to ISO 9001 and ISO 13485 in the fields of development, production and selling of hard tissue implants.

click to view as PDF file    click to view as PDF file

A reference to the Medizinproduktgesetz (Medical Device Law)
According to the UMDNST (Universal Medical Device Nomenclature System) 3di skull implants belong to the category of custom devices.

Our skull implants are licensed according to MPG and Medizinproduktverordnung (Medical Device Regulations) standards.

Thus, they meet the requirements of the European Union directives 93/42.

 

Thanks to modern analysis and simulation procedures based on the method of finite elements, it is possible to simulate, in the preoperative phase, realistic resistance cases for each implant model and material.

   


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