astm standards , Solidworks, ISO 11607-2, ISO 15883 cleaning validation, ISO 17665 steam sterilization, Creo, EU-MDR compliance, Agile PLM systems, Microsoft Project, ISO 11607-1, SAP process flows, e-IFU processes, Distribution simulation testing, Fit checks, Project management, Packaging test protocols, Perforation assessments, Reusable and single-use packaging solutions, Technical File remediation