Medical Devices and Biomaterials

Heiko Steuer
Testing Services

+49 7121 51530-839

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In the biological evaluation process of medical devices and biomaterials the material characterization is a crucial first step. Identification of material, chemical constituents and consideration of chemical characterization shall precede any biological testing. And physical effects of the device shall be considered if they impact the biocompatibility (DIN EN ISO 10993-1). 

Biological safety studies are part of the conformity assessment for medical devices. The material, coating, final product and the whole manufacturing process have to be evaluated for the biological risk.

• Chemical characterization (extractables, leachables)

• Functionality of materials (stability, degradation, drug release)

• Rheological studies

• Polydispersity

• Endotoxicity (LAL, MAT)

• Drug release (combination products)

• Development of analytical methods for special questions during you product development