Services
EU MDR CLINICAL EVALUATION
EU MDR CLINICAL EVALUATION
EU MDR CLINICAL EVALUATION
Draft Clinical Evaluation Packages, including Clinical Evaluation Plans and Reports (CEP, CER), Summary of Safety and Clinical Performance (SSCP), Post Market Clinical Follow Up Plans and Reports (PMCF), Product Safety Update Reports (PSUR), Annual Summary Reports (ASR) to demonstrate compliance with EU MDR and conformity with the MDD regulations, securing CE marking for your medical devices.
Manuscript writing
EU MDR CLINICAL EVALUATION
EU MDR CLINICAL EVALUATION
Present clinical study data in a clear and compelling manner in scientific manuscripts, and submit to journals, in alignment with the ICMJE guidelines, in collaboration with selected author group.