Verifying the efficacy and potential adverse effects (toxicity) of your test item is valuable already at the research stage of your project.
This data is highly crucial not only in selecting the most potential material or composition for further development but also in advising you in the design of regulatory studies. The efficacy studies are non-GLP studies, but your study reconstruction is always ensured through adequate documentation of a study conduct and archiving of data.
MADE supports you in biomaterials research with in vivo models and state-of-art techniques (according to ISO 10993 -guidelines). Our comprehensive research approach yields more information from a single study.
Made can help you in your medical device development process by:
- planning and designing the test strategy (biocompatibility test strategy / risk assessment)
- helping with efficacy studies (planning, performing and reporting)
- absorption studies (bone)
- helping with biocompatibility tests (CRO managing)
- project management
- writing the biocompatibility report for CE marking application, written by European Registered Toxicologist
MADE has also personally audited and signed partnership agreements with some of the CROs offering regulatory medical devices testing services (GLP-studies for CE marking application).