Medical Devices and Biomaterials

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.

According to DIN EN ISO 10993 the selection of required biological tests is based on the contact and the contact time of the device in the human body.

  • 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