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EudraLex - Volume 4 - Good Manufacturing
Code of Fedral Regulations
GOOD MANUFACTURING PRACTICE (CGMP)
THE EU MEDICAL DEVICE REGULATION (MDR)
MDSAP PROGRAM
QS UNDER EN ISO 13485, US FDA QSR - GMP
DESIGN CONTROL EN ISO13485&21CFR 820
Apply Risk MGMT to medical devices
PROCESS VALIDATION INCLUDING SOFTWARE
LITERATURE ROUTE FOR CLINICAL EVALUATION
POST-MARKET SURVEILLANCE AND VIGILANCE
THE NEW EU IVD REGULATION (IVDR)
CLINICAL EVIDENCE -- IVDR
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