A Comprehensive View of FDA Regulations for Medical Devices

Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820.

Topics: US medical device regulations, FDA medical device compliance best practices, FDA QSR, medical device reports (MDR), Unique Device Identification (UDI), Quality System Inspection Technique (QSIT), FDA inspections, medical device manufacturer, form 483s, warning letters, Part 820, quality management system, quality assurance and quality control, device marketing requirements, CAPA, device design requirements