FDA Guidance Document (draft) Medical Device Reporting
Labeling regarding NO Latex content
Guidance for Notified Bodies auditing suppliers
to medical device manufacturers
FDA General Principles of Software Validation
FDA Process Validation General Principles and Practices
GHTF Study Group3 - Process Validation
GHTF Study Group3 - Products & Services Obtained from Suppliers
FDA Inspection of Medical Device Manufacturers
Video - Kim Trautman (FDA - CDRH) overview of QSR
FDA Medical Device Quality Systems Manual
Guidance on Medical Devices Vigilance System