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Medical devices: Acronyms/Abbreviations

The medical devices industtry is full of Acronyps/Abbreviations and many a times we struggle to find which one is which, so following is the list of some of them that you may like to refer:

DDP                     Distinct Dose Pen 

DHF                     Design History File per FDA Regulation 21 CFR 820

DHR                     Device History Record

DMR                    Device Master Record 

DSA                     Development and Service Agreement

QTA                    Quality and Technical Agreement

MSA                    Manufacturing and Supply Agreement

EEC                      European Economic Community

DV                       Design Verification/ Design Validation

FAT                      Factory Acceptance Test

FDP                      Fixed Dose Pen

GMP                    Good Manufacturing Practice                  

HFF                      Human Factor Formative Studies

HFS                      Human Factor Summative Study

SAT                      Site Acceptance Test

V&V                     Verification and Validation

FDA                     Food and Drug Administration

EMA                    European Medicines Agency

RLD                      Reference Listed Drug


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