Quality lab for diagnostic and medical devices

Quality testing along the entire value creation chain

In the case of medical products and diagnostic devices, safety is the priority. We therefore carry out extensive testing in the areas of materials, geometry and function during all phases of product origination. Our quality lab has a measuring lab for the geometric measurement of components, assembly units and finished products, a lab for material analyses and a lab for functional testing with product-specific testing equipment.

Your PLUS with Gerresheimer

Our material analysis lab is responsible for the incoming goods inspections and raw materials approvals worldwide. There we carry out material-specific, physical and chemical analyses of plastic granulates and create damage analyses for incorrectly manufactured components where necessary. In addition to the spectroscopic analysis (FTIR) and the established procedure for thermal analysis (MFR/MVR, DSC, TGA), our extensively equipped lab also offers the possibility of a physical-chemical analysis of viscosity, residual moisture and density, as well as an infra-red spectrometer and a thin section microscope. The know-how for the development and execution of customer-specific methods round off our analysis portfolio.

A measurement lab with the most modern measurement machines ensures that complex mold inserts and sophisticated injection molding parts or assembly units can be measured extremely precisely. The complete component measurement is thereby documented in the initial sample test report. The equipment includes the most varied multi-sensor coordinate measurement machines for visual and tactile component measurements, universal measuring microscopes and an industrial computer tomograph for destruction-free measurement and testing of individual components or entire assembly units.

We develop and qualify test methods for guaranteeing the observance of product-specific requirements in our functional testing lab. We ensure more safety for patients through extensive measurements of the physical product properties, product-specific functional tests and statistical data analysis (e.g. regression calculation, variance analysis, process capability examination, design of experiments) during product development of diagnostic products and medical products. In addition to force/torque tests and seal tests, we use 6-axis robots, for example, to simulate the robustness of the trigger function of lancing devices. We carry out aging and climate tests, as well as fall tests for documenting device function under extreme conditions. With the help of high speed cameras, we visualize the complex interplay of device components that move too quickly for the human eye.

Contact us!

Sophia Rueckerl
Sales Europe

Phone: +49 9431 639 6971
E-Mail: Sophia Rueckerl

Aron Haber
Sales North America

Phone: +1 770 688 5000
E-Mail: Aron Haber

Mike Nie
Sales Asia

Phone: +86 769 8851 7100 317
E-Mail: Mike Nie