Opinions expressed by Digital Journal contributors are their own. In today’s environment, the need for a quality management system is not merely a luxury. Still, instead, it is an essential ...
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, ...
Firms with A&A practices should pay particular attention to the new standard on engagement quality reviews (EQRs) as they implement the new suite of quality management (QM) standards that are ...