QMS establish (GMP/GSP, MDSAP, ISO 13485, QSR 820)
Regulation introduce, MD classification, registration strategic, Usability research
Design procedure, Risk Management, usability engineering, software development, cybersecurity, design verification and validation
Type testing, Brazil INMETRO, Usability summative testing, Cybersecurity, Reprocessing, 21 CFR Part 11 Verification and validation
CE MDR/IVDR
FDA510K
NMPA
MDSAP/ISO 13485
Adverse event monitoring
Risk analysis
Design change control
PSUR(Periodic Safety update report)
PMCF(Post Market Clinical Follow-up)
