Why Should You Attend: The FDA’s QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. These are Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Quality System Record (QSR). An FDA inspection will focus on the records you maintain. These records provide the objective evidence that demonstrates your QMS operates the way it should. While procedures are important, the supporting records demonstrate that you follow your own procedures.Areas Covered in the Seminar:The FDA’s QSR. The source of the requirementsThe preambleThe QSR ManualOMB information collectionKey DefinitionsDesign History File (DHF). RequirementsContentQuality System Record (QSR)