Biocompa­tibility

We help you quickly and accurately create ISO 18562, ISO 10993, and FDA-compliant biocom­patibility files

Manufacturers must prove the biological safety of the materials used in medi­cal devices that come into contact with the human body, either directly or indirectly through gases or fluids. 

However, many of those responsible are un­clear about the legal require­ments they must comply with, whether existing data is sufficient for the evaluation, or what the final documen­tation must look like to avoid deviations and, thus, delays in device approval. 

With our support, you are on the safe side.

Our experts support you in all documentation tasks related to the biocompa­tibility of your medical devices

• We create your complete biocompatibility file if required. 

• We create individual reports and docu­ments, such as the biological evaluation plan (BEP), the toxicological risk assessment (TRA), or the biological evaluation report (BER). 

• We take over the literature search for material, leachables, and extrac­tables and evaluate the biocompatibility based on the laboratory results.  

• We check your existing data and docu­ments for conformity with standards, guidelines, and laws and provide you with targeted suggestions for improvement.