RQM+ Medical Device and In Vitro Diagnostic Blog

on 23 May 2013 | By Ryan Kasun

In my last post “Who’s watching your MedWatching”, I commented on some of the common issues manufacturers have with their MDR and complaint handling systems. It’s useful to know what people are doing wrong, but I think it is equally important to know how to solve those issues....

on 3 May 2013 | By Ryan Kasun

Last year, FDA received almost one million adverse event reports from manufacturers1. Needless to say, the Office of Surveillance and Biometrics has been very busy, and so have manufacturers.