Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...
Lack of an effective complaint management system is one of the more frequent Form 483 observations cited during FDA device establishment inspections. In fact, failure to process complaints in a timely ...
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 ...
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