Manufacturers of medical technology instruments and devices are increasingly being required to demonstrate the quality of their products. A comprehensive process and quality assurance system is therefore becoming ever more important. An analysis of the surface, in molecular dimensions, as well as careful testing during assembly are crucially important in the evaluation of product characteristics, such as a material's susceptibility to corrosion after laser labelling, or its cleanness or the reliability of bonding.
Highly-sensitive methods are required to determine elements and chemical bonds on surface structures. They thereby contribute to the validation of processes.
Quality certification for medical devices
The NMI establishes and qualifies manufacturing and cleaning processes and analyzes surfaces after processing, sterilization and utilization. In addition, the NMI offers support in the biological assessment of products.
Our clients from the medical technology field have complete access to our expertise, ranging from biology to surface and material technology. This enables them to achieve conclusive and reliable outcomes and credentials that ensure quality assurance and regulatory approval of their products.
The NMI offers a wide range of methods in accredited areas according to DIN EN ISO / IEC 17025:2005 for testing materials and their surfaces.
- Certificate Medical Devices (pdf download)
- Certificate Materials (pdf download)