eMDR

Even after decades of eQMS availability, a staggering number of projects still suffer when the QMS implementation team isn’t right, ready and responsible.  Regardless of your QMS software [...]

Risk management and adverse event reporting protocols for medical device manufacturers have been addressed by a new FDA guidance. Producing and controlling electronic records will be critical to [...]

It’s been a little while since we checked the FDA’s outgoing mail tray to find out what inspectors are looking for – and often finding – during their visits in the first half of 2015 We start [...]