Specialized in:-Biological Evaluation Plan and Biological Evaluation Report of medical devices; -Chemical characterization, biocompatibility, and toxicological risk assessment of medical devices; -Literature review, sample size calculations, and statistical calculations for clinical studies of medical devices and in-vitro diagnostic medical devices; -Clinical Evaluation Reports on medical devices (FDA, MDD, and MDR compliant); -Performance Evaluation Reports on in-vitro diagnostic medical devices (FDA, IVDD, and IVDR compliant); -Technical writing on medical devices (FDA, MDD, and MDR compliant) and in-vitro diagnostic medical devices (FDA, IVDD, and IVDR compliant).#medicaldevices #invitrodiagnostics #mdr #ivdr #biocompatibility #toxicology #biostatistics #clinicaltrial #clinicalevaluation