11 In vivo test Preparation of documentation for obtaining approval to perform in vivo studies of the effectiveness and biodistribution of pharmaceuticals in pathological models using small rodents. Monitoring by means of in vivo imaging with the IVIS LUMINA III PerkinElmer imaging system is possible. Ad hoc biocompatibility studies for materials can be conducted. testing services evaluation services (pre & post market) development services 13 Services Assistance to companies for: • Toxicological Risk Assessment (TRA) (ISO 10993-Part 17) and Toxicological Expert Reports, approved by ERT (European Registered Toxicologist) • Biological Evaluation Plan / Report (BEP / BER) • Clinical Evaluation Plan / Report (CEP / CER) • Post Market Clinical Follow-up (PMCF) Plan and Report evaluation services (pre & post market) development services testing services Scientific publications, ethical committees and industrial patents (available on request) 12 Usability Consultation services to verify the ergonomics of medical devices in accordance with standard IEC 62366. evaluation services (pre & post market) development services testing services
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