The Food and Drug Administration is investigating how a contracted document management company accidentally made public 75,000 pages of confidential FDA files related to approval of medical devices, ...

The Food and Drug Administration is investigating how a document-management company inadvertently made public some 75,000 pages of confidential agency files about the approval of medical devices, FDA ...

Defective medical devices — and the lack of laws or enforcement against them — have killed thousands of patients around the world and put millions more at risk. Yet, in my country and many others, few ...

A well-written procedure documenting the complaint management process, including the creation of a complaint form, is required by the QSR. By Bob Mehta I have always experienced great difficulty in ...