Physico-chemical characterization of materials

The EU Medical Device Regulation (MDR) and the FDA require a very comprehensive physicochemical characterization of medical devices, especially for new materials, coatings or nanostructures. The aim is to prove safety, stability and biological harmlessness. Our tests comply with requirements such as ISO 10993-18, ISO 10993-19, ISO 10993-1 and other relevant standards.

We support you with a broad portfolio of analytical and development-related services to ensure the regulatory compliance and functionality of your materials: 

• Consulting and evaluation: development of test plans, evaluation of customer-owned test reports, conceptual support for development projects
• Approval-relevant tests: Physicochemical characterization according to MDR and ISO 10993 series (e.g. -13, -15, -18, -19), incl. degradation products, release kinetics, simulated application
• Active substance and release analysis

Our methods: 

• QCM, ellipsometry, REM1, TOF-SIMS 
• MALDI-TOF, SEC, DSC 
• DLS, zeta potential, rheology
• ICP-MS
• HPLC1, UV/Vis1, GPC

1 are accredited methods according to ISO 17025

In addition to standardized tests, we also support your R&D projects with tailor-made analytical solutions. Whether feasibility studies, material selection or prototype evaluation - our interdisciplinary expertise helps you to bring innovative materials to market faster.