FDA Regulatory Compliance for Medical Devices

Training and the FDA – What do they want?

The FDA requires medical device and drug manufacturers to train their employees. Training must occur for all types of regulated activities from internal quality management procedures/policies to CFR requirements. The agency expects companies to establish comprehensive procedures that not only detail how the staff will be trained but also complies with the Q [...]

FDA vs. EU Inspections: Similarities and Differences

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009. The program targets investigator sites, sponsors and contract research organizations (CROs) in either the US or the European Union (EU).   These join [...]

Training and the FDA – What do They Require?

The FDA requires medical device and drug manufacturers to train their employees. Training must occur for all types of regulated activities from internal quality management procedures/policies to CFR requirements. The agency expects companies to establish comprehensive procedures that detail how staff members will be trained, but also complies with the QSR re [...]