Eu Mdr Specialty Content Author
CurrentResponsible for rewriting CE Technical files to comply with the new MDR regulation.• Consulted with subject matter experts to evaluate CE Technical file content, identify potential gaps in compliance and identify the best studies to ensure compliance with the new MDR regulation.• Authored STED technical sections including sections for Biocompatibility; Physical, Chemical and Microbiological Characterization; Stability and Shelf-Life and Performance and Safety.